23-04-2021



TiLite Manual Wheelchairs. Phone: 800-736-0925 Fax: 866-586-2413 customerservice.tilite@permobil.com. Phone: 800-736-0925 sales.smartdrive@permobil.com. . If unsure, send us an email to orders.au@permobil.com with the serial number of the chair and a picture of the part you require PROGRAMMING AND RNET SOFTWARE 1.

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Class 2 Device Recall Permobil powered wheelchairs
Date Initiated by FirmAugust 15, 2018
Create DateSeptember 15, 2018
Recall Status1Open3, Classified
Z-3178-2018
Recall Event ID80686
Wheelchair, powered - Product CodeITI
ProductPermobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS
Product Usage:
The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered wheelchair.
Code Information(a) M300 PS, Serial numbers: 2572023019 2572000069 2572000403 2572000293 2572000358 2572000298 2572000359 2572000089 2579000025 2572018895 2572018959 2572000487 2572000491 2572000488 2572000492 2572000489 2579000027 2572000490 2572000493 2572000736 2572000367 2572000766 2572000816 2572000905 2572000924 2572000765 2572000299 2572006070 2572017706 2572024924 2572000735 2572024257 2572003615 2572001137 2572001149 2572001168 2572001169 2572001289 2572001170 2572001324 2572015685 2572015835 2572000402 2572001470 2572001546 2572001649 2572001650 2572001468 2572001471 2572001739 2572001798 2572001757 2572001851 2572001758 2572001379 2572001829 2572001859 2572001756 2572001860 2572002162 2572002521 2572002696 2572002941 2572002960 2572002085 2572001738 2572002163 2572002275 2572002054 2572002277 2572002449 2572002695 2572002697 2572002940 2572003044 2572003043 2572003045 2572003027 2572003231 2572003367 2572003402 2572003403 2572003550 2572003515 2572003565 2572003618 2572003804 2572003863 2572004017 2572024869 2572024934 2572003867 2572004018 2572004053 2572024343 2572024870 2572024318 2572024300 2572004211 2572004325 2572004369 2572004372 2572004312 2572004371 2572024234 2572023921 2572004542 2572004373 2579000258 2572004612 2572004613 2572004618 2572024388 2572023131 2579000839 2572023068 2572000367 2572004760 2572004968 2572004707 2572004967 2572005018 2572005019 2572004621 2572005021 2572005057 2572005058 2572005055 2572005059 2572005062 2572005064 2572005056 2572005210 2572005213 2572005211 2572005214 2572005218 2572005337 2572005412 2572005557 2572005602 2572005617 2572005618 2572005651 2572005688 2572005690 2572005691 2572005739 2572000401 2572000680 2572002161 2572001136 2572000812 2572001181 2572001138 2572006042 2572006078 2572006095 2572006129 2572006146 2579000282 2572006301 2572006440 2572006272 2572006393 2572006424 2572020015 2572019837 2572006702 2572006483 2572006471 2572006531 2572006532 2572006703 2572006772 2572006484 2572006805 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2572017540 2572017525 2572017480 2572017472 2572017468 2572016672 2572013237 2572013340 2572016622 2572016580 2572016565 2572016550 2572016507 2572015912 2572015744 2572015664 2572015656 2572015653 2572015645 2572015483 2572013617 2572013706 2572013642 2572013711 2572013745 2572013715 2572013790 2572013893 2572013896 2572013901 2572013843 2572013906 2572013944 2572013947 2572013958 2572013965 2572013959 2572014078 2572014089 2572014091 2572014126 2572014128 2572013932 2572014001 2572014148 2572014231 2572014166 2572014282 2572014301 2572014245 2572014283 2572014385 2572014396 2572014414 2572014467 2572014490 2572014501 2572014502 2572014480 2572014489 2572014504 2572014506 2572014619 2572014700 2572014744 2572014785 2572014790 2572014827 2572014913 2572014930 2572014932 2572014934 2572014953 2572015004 2572015005 2572015013 2572015093 2572015179 2572015185 2572015222 2572015272 2572015322 2572015338 2572015341 2572015324 2572015326 2572015376 2572015397 2572014750 2572015450 2572015406 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2572004376 2572004218 2572004210 2572004057 2572004056 2572004054 2572004016 2572003617 2572003609 2572003566 2572002942 2572002623 2572002586 2572002585 2572009732 2572018956 2572017707 2572006441 2572007981 2572024299 2572003610 2572001049 2572002446 2572002959 2572004055 2572017677 2572019719 2572019817 2572009924 2572015725 2572010030 2572010015 2572017978 2572017974 2572018022 2572018044 2572018075 2572018107 2572018177 2572018324 2572018409 2572018157 2572018556 2572018181 2572018233 2572018481 2572018552 2572018482 2572018633 2572018538 2572018695 2572018619 2572018731 2572018800 2572018827 2572018843 2572017969 2572009844 2572010075 2572009602 2572009692 2572009789 2572009863 2572010158 2572009937 2572018738 2572018710 2572018869 2572019008 2572019050 2572019163 2572019272 2572019284 2572019296 2572019320 2572019468 2572019311 2572019469 2572009723 2572010074 2572009028 2572009708 2572002447 2572001741 2572006039 2572006018 2572005972 2572005767 2572005954 2572007608 2572006014 2572004703 2572004705 2572020083 2572020090 2572020176 2572020225 2572019369 2572020255 2572020273 2572020284 2572020361 2572020278 2572020365 2572020418 2572020420 2572020462 2572020552 2572020566 2572019359 2579000787 2572020304 2572019516 2572020715 2572020770 2579000790 2572020826 2572020847 2572020849 2572020966 2572020982 2572021054 2572021065 2572021071 2572020750 2572020916 2572020812 2572021223 2572020919 2572021130 2572021269 2572021293 2572021599 2572021565 2572021657 2572021672 2572021689 2572021693 2572021708 2579000817 2572021947 2572021954 2572022119 2572022053 2572022159 2572022175 2572022223 2572022242 2572022241 2572022225 2572022255 2572022400 2572021787 2572022408 2572022406 2572022549 2572004541 2572004552 2572022699 2572022780 2572022777 2572022808 2572022834 2572022825 2572022866 2572022920 2572022806 2572023358 2572022858 2572023433 2572023439 2572023482 2572023479 2572023586 2572023597 2572023644 2572023651 2572023685 2572023686 2572023756 2572023905 2572023963 2572023994 2572024088 2572024478 2572024529 2572024533 2572024542 2572024636 2572024645 2572024668 2572024780 2572024733 2572024930 2572025102 2572025114 2572025106 2572025136 2572025152 2572003140 2572025192 2572025181 2572025240 2572025285 2572025403 2572025396 2572000195 2572001173 2572001180 2572001755 2572001828 2572001759 2572001799 2572002056 2572003369 2572003865 2572004276 2572024444 2572005142 2579000367 2572007422 2572008420 2572008450 2572008727 2572008830 2572008804 2572009230 2579000208 2572018903 2572018902 2572010502 2572010857 2572010901 2572010927 2572011229 2572011503 2572017832 2572013708 2572013894 2579000604 2572013613 2572015941 2572016287 2572016803 2572003612 2572002672 2572002671 2572002622 2572002522 2572020202 (b) C300 PS, Serial Numbers: 2597000037 2535002420 2597000038 2597000039 2539000132 2535002472 2535003490 2597000042 2535002640 2535002641 2597000043 2535002755 2535002756 2597000045 2597000044 2535002798 2597000046 2597000040 2535002799 2535002902 2535002903 2535002970 2597000049 2535003007 2597000050 2535003052 2535003051 2597000052 2535003183 2535003312 2597000054 2597000051 43404260 2535003304 2535003313 2535003314 2597000058 2535003366 2597000055 2597000059 2597000060 2597000062 2597000041 2597000069 2597000053 2597000092 SEATONLY 2597000066 2597000067 2535003550 2597000086 2597000063 2597000088 2535003554 2535003673 2535003835 2597000071 43601521 43601521 2597000075 2597000073 2535003919 2597000077 2535003920 2597000076 2597000080 2597000078 2597000079 43401071 43402679 43403247 SEATONLY SEATONLY 2597000087 2535016620 2535018784 2539000248 2535005833 2535006097 2597000094 2597000173 2535006094 2535004501 2535004500 2597000098 2535016249 2535006017 2597000101 2597000100 2597000103 2535004787 2597000105 2597000104 2597000106 2535005383 2597000131 2597000108 2535005081 2597000107 2535018780 2535018814 2535018933 2535018972 2535012416 2535012644 2535014137 2535014672 2535015308 2535015361 2535015379 2535015455 2535016525 2535016567 2535016753 2535016790 2535009460 2535005520 2535005522 2535005524 2535009460 43506653 43402679 43401071 2535004018 2535004103 2535005590 2597000121 2597000124 2597000123 2597000122 2535005676 2535005677 43403007 2535005798 2539000342 2597000127 2535005832 2535004104 2535016861 2535017032 2535017040 2535005020 2535014055 2535008578 2535008464 2535009997 2535005929 2535006203 2597000135 2597000091 2535010153 2535015433 2535018774 2539000356 2597000130 2597000132 2535015538 2535004449 2597000134 2535006159 2535006158 2535018955 2535018964 2597000137 2535006204 2597000138 2535006281 2597000141 2535006296 2535018982 2597000068 2535006592 2535006735 2535006736 2597000144 2535006508 2539000417 2535006884 2535006885 2597000145 2535006974 2535006973 2597000146 2535007176 2597000147 2597000148 2535007315 2535007345 2597000113 2597000096 2597000070 2535018648 2597000151 2535007470 2597000152 2535007521 2597000154 2535007648 2535007666 2597000155 2535007625 2539000470 2535007749 2535016807 2535016788 2597000161 2597000158 2539000472 2597000156 2597000157 2597000162 2535007759 2535007821 2597000163 2535007865 2539000489 2597000164 2535008001 2535008034 2535008243 2597000166 2597000167 2597000168 2597000169 2535008015 2535008289 2535008334 2535008337 2535008381 SEATONLY 2535008420 2535008426 2597000170 2535000933 2535016809 2535018922 2539000907 2597000082 2535008477 2535007399 2539000906 2597000112 2597000114 2597000115 2535014074 2535004450 2535008744 2535008873 2535008910 2535008871 2535008950 2535008915 2535009012 2535008958 2597000175 2535009127 2535009168 2535009033 2535009135 2535009022 2535009111 2535009166 2535009172 2535009174 2535009186 2535009234 2535009350 2535009348 2535009458 2535018705 2597000149 2535009209 2535016339 2597000159 2535004788 2597000129 2535010082 2535009538 2535009545 2535009599 2535009803 2535009811 2535009834 2535009846 2535009893 2535009897 2535009910 2597000176 2535009924 2535015636 2535016772 2597000109 2597000186 2597000174 2597000171 2597000143 2597000142 2597000133 2597000120 2597000036 2535010201 2535010242 2535010278 2539000603 2535010129 2535010351 2535010184 2535010264 2535010303 2535010335 2535010301 2597000177 2539000607 2535010363 2535010476 2535010503 2535010418 2535010530 2535010522 2597000178 2535010560 2535010590 2535010574 2535010753 2535010796 2535010711 2535011004 2535010923 2535011005 2535011117 2535011121 2535011128 2535011198 2535011207 2535011246 2535011218 2535011283 2535011275 2597000179 2535011359 2535011363 2535011408 2597000180 2535011450 2535011505 2535011506 2535011574 2535011591 2597000181 2535011592 2597000182 2535011582 2597000183 2597000185 2597000184 2535011641 2535011763 2535011961 2535011962 2535012004 2535012052 2535012053 2539000724 2535012249 2535012281 2535012580 2535012703 2535012705 2535012723 2535012724 2535012735 2535012762 2535012779 2535012784 2535012807 2535012892 2535012808 2535012937 2535012894 2535012965 2535012966 2535013073 2535013087 2535013065 2535013160 2535013181 2535013183 2535013201 2535013246 2535013260 2535013271 2535013411 2535013428 2535013444 2535013457 2535013460 2535009460 2535013522 2535013535 2535013603 2535013612 2535013609 2535013661 2535013543 2535013674 2535013730 2535013777 2535013778 2539000797 2535013883 2535013961 2535013962 2535014197 2535014276 2535014274 2535014309 2535014374 2535014403 2535014429 2535014479 2535014484 2539000819 2535014590 2535014736 2535014693 2535014858 2535014866 2535014888 2535014992 2535014964 2535015106 2535015078 2535015087 2535015091 2535015124 2535015207 2535015307 2535015309 2535015345 2535015320 2535015332 2535015705 2535015711 2535015684 2535015696 2535015746 2535015737 2535015758 2535015768 2535015786 2535015808 2535015923 2539000873 2535015971 2535015978 2535016019 2535016022 2535016027 2535016045 2535016015 2535016078 2535016080 2535016079 2535016160 2535016161 2535010099 2535010185 2535009940 2535009478 2535010002 2535016319 2535016351 2535016311 2535016385 2535016403 2535016408 2539000890 2539000891 2535016467 2539000897 2535016509 2535016516 43701931 2535016531 2535016585 2535016590 2535016596 2535016621 2535008737 2539001012 2539000601 2535018853 2535018848 2535018842 2535018838 2535018817 2535018802 2535016862 2535016822 2535016273 2535016238 2535016176 2535016044 2535015616 2535015602 2535007758 2597000172 2535007369 2535006387 2597000140 2535017149 2535017160 2539000924 2535017189 2535017161 2535017228 2535017267 2535017260 2535017198 2535017298 2535017303 2535017332 2535017333 2535017334 2535017348 2535017313 2535017444 2535017425 2535017476 2535017482 2535017505 2535017508 2535017480 2535017503 2535017506 2535017607 2535017630 2539000946 2535017639 2535017667 2539000947 2535017715 2535017631 2535017709 2535017743 2535017760 2535017779 2535017794 2535017756 2535017802 2535017814 2535017809 2535017837 2535017945 2535017983 2535017875 2535018091 2535018099 2539000949 2535018125 2535018105 2535018146 2535018154 2539000961 2535018256 2535016713 2535016713 2535018375 2535018419 2535018436 2539000971 2535018499 2535018514 2535018563 2535018422 2535018592 2535018482 2535018637 2535018639 2535018641 2535018644 2535018642 2535018643 2535018674 2535007484 2535006385 2535015535 2535015512 2535015472 2535018715 2535018730 2535015454 2535015400 2535015371 2535015343 2535015335 2535015329 2535015321 2535016175 2535014636 2535014626 2535012658 2535012646 2535012600 2535012491 2535012387 2535012386 2535012358 2535010158 2535018891 2535018900 2535018901 2535018899 2535018903 2535018904 2535018907 2535018909 2535018908 2535018910 2535018916 2535018912 2535018914 2535018920 2535018930 2535005831 2535005217 2535005019 2535018934 2535018938 2535018941 2535018946 2535018947 2535018949 2535018950 2535018967 2535018983 2535018980 2535018988 2535018986 2535018990 2535018994 2535018991 2535018989 2535014052 2597000048 2597000057 2597000083 2597000093 2597000187 2535018942 2597000165 2535016849 2535016826 2535008845 2597000118 2535010620 2539000677 2535013869 2535013865 2535015770 2597000160 2535017524 2535015530 2535015456 2535008786 (c) C350 PS, Serial Numbers: 43203064 43203079 43201298 43201298 43101303 43101267 43101275 43203098 43101287 43101289 43203108 43202697 43101290 43101300 43101295 43203162 43203179 43203192 43101340 43101464 43101491 43203212 43203216 43203218 43203265 43101509 43101524 43200756 43203298 43203444 43203578 2531000003 2532000027 2532000076 43101439 43101465 43101477 43101443 43203458 43203535 2532001482 2532001500 2532001533 2532000040 43201617 2532000042 43101514 43101521 2532000062 43101617 SEATONLY 43101553 2532001472 2532000090 2532000111 2532001431 43101320 2532000146 43101572 2532000159 43101593 43101617 43101334 43101308 2532001227 43101610 2532001216 2531000001 2532000213 2532000251 2532000262 2532000249 2532000269 2532000296 2532000284 2532001195 2532000159 2532000336 2532000364 2532000369 2532000373 2532000378 2532000383 2531000004 2532000389 2532000401 2532000395 2532000419 2532000434 2532000430 2532000437 2532000454 2532000453 2532000455 43200756 2532000494 2532000493 2532000498 2532000499 2531000005 2532000510 2531000006 2532000539 2532000532 2531000007 2532000557 2531000008 2532000601 2532000597 2532000598 2532000617 2531000009 2532000626 2532000643 2532000659 2532000663 2532000664 2532000661 2532000666 2532000674 2532000673 2532000729 2532000734 2532000742 2532000766 2532000777 2532000779 2532000781 2532000787 2532000780 2532000792 2532000799 2532000839 2532000845 2532000854 2532000856 2532000880 2532000888 2532000890 2532000892 43200453 43200453 2532000939 2532000938 2532000940 2532000946 2532000945 2532000766 2532000963 2532000958 2532001001 2532001007 2532001042 2532001040 2532001034 2532001037 2532001052 2532001061 2532001064 2532001129 2532001144 2532000420 2532000446 2532000477 2532001166 2532000132 2532001230 2532001231 2532001244 2532001250 2532001251 2532001253 2532001274 2535017169 2535017169 2532001293 2532001298 2532001304 2532001315 2532001328 2532001362 2532001366 2532001384 2532001407 2532001426 2532001428 2532001430 2532001450 2532001467 2532001390 2532001373 2532001198 2532001088 2532001082 2532001078 2532001075 2532000981 2532000977 2532000976 2532000927 2532000922 2532000915 2532000748 2532000725 2532000708 2532000478 2532001478 2532001491 2532000469 2532000463 2532000457 2532000334 2532000320 2532000300 2532000297 2532000117 2532001508 2532001515 2532001525 2532001527 43101558 43101563 2532000371 2532000511 2532000555 2532000722 2532000831 2532001421 2532001408 (d) C500 PS, Serial Numbers: 2557000479 2557000768 (e) C400 PS, Serial Numbers: None- seat only
Recalling Firm/
Manufacturer
Permobil, Ab
Arvaltsvagen 10
Box 120
Timra Sweden
For Additional Information ContactMs. Jamie Crawford
615-975-7463
This correction decision has been made because of a potential failure of one or both backrest bars providing back support. If one or both back support telescoping bars fail the user could fall back leading to a potential injury.
Device Design
The firm initiated the recall on 08/15/2018 by letter to the direct accounts (dealer/distributors). The letter instructed the consignee to contact the end users and perform the correction.
3134 units
Worldwide Distribution - US Nationwide
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = ITI and Original Applicant = PERMOBIL A.B.
510(K)s with Product Code = ITI and Original Applicant = PERMOBIL AB

How do I obtain product literature?

You can obtain hard copies of brochures and literature by contacting Permobil Australia at info.au@permobil.com.

You may also download PDFs from the TiLite product pages.

Permobil Serial Number

Where can I find the serial number of my chair?

All TiLite chairs have a black and silver tag that indicates the serial number. You will not likely be able to see it while seated in the chair. It will not contain any letters, only numbers.

Folding Chairs
The serial number is located on the left side frame on the bottom of the chair.

Rigid Chairs
The serial number is located on the welded cross bar located directly under the seat upholstery.

I need parts for my TiLite chair: can I purchase them directly from TiLite?

To purchase parts in Australia, please contact our Customer Service on 1300 845 483 or email orders.au@permobil.com.

TiLite no longer builds my model of chair: why? What new model is most comparable?

We are constantly updating our wheelchair designs, and it is sometimes necessary to stop production on older models. We will do our best to meet individual needs with our existing product line and maintain a small inventory of parts for discontinued models. Many design changes are made to improve the original models as newer innovative technologies become available. If you are not sure how to choose a new model, contact an authorized TiLite dealer in your area. They are there to help you with the process of choosing a new TiLite chair or getting you parts to maintain your current model.

Find a list of Authorized TiLite Dealers in your area.

How often does a TiLite chair require service or maintenance?

TiLite chairs should be serviced by an authorized TiLite Dealer at least once a year. Your wheelchair should be inspected weekly to ensure all components are tight and working properly. Never use a chair with missing or broken components. Please refer to your owner’s manual or relevant supplemental information for details.

If my chair needs service, who do I call?

If your chair needs service, please contact the dealer who originally provided your chair. If you do not remember who provided your chair, Permobil Australia keeps a record of dealers for your reference.

Find a list of Authorized TiLite Dealers in your area.

Can I touch-up the paint on my TiLite myself?

For touch-up paint, options include hobby shop touch-up paint or automotive touch-up paint, but our experience has taught us that Rustoleum spray paint is the best option – more durable and better finish. What we recommend is lightly sanding the area you want to touch-up, taping up parts you don’t want painted, and then spraying. Here is a link to the color options page on Rustoleum’s website.

Does TiLite offer a transit tie-down option?

Yes. Transit Tie-Downs are available on the ZRA, Aero Z, Aero X, and TWIST models.

Is a TiLite chair compatible with a lock down system for vehicle travel?

TiLite wheelchairs are not designed to be used for seating in a motor vehicle. For this reason, TiLite does not recommend use of a lock down system.

Does TiLite offer demo chairs?

Yes. Examples of all of TiLite’s wheelchair models are available as demo chairs in the field. To arrange to view or trial a TiLite chair, contact a local TiLite dealer and they will work with the local sales representative to organize an appointment. Please note that the demo chairs available may not be the exact specification you are looking for, but each final order is customized to meet your specific needs.

Find a list of Authorized TiLite Dealers in your area.

What is the weight capacity for TiLite chairs?

A weight capacity of 120 kg is standard for most TiLite chairs. TiLite offers a Heavy Duty option on the ZR, ZRA, 2GX, and Aero X chairs that can accommodate 136 kg to 158 kg. Chairs that are smaller than 12″ by 12″ have a 75 kg weight limit.

What is a uni-lock wheel lock?

Uni-Lock actually stands for “Universal Lock.” It is a wheel lock with several adjustment points that allow you to change handle angle and engagement direction. These features are designed to improve the users function by adjusting the wheel lock to better meet their needs. The Uni-Lock does not operate the wheel locks for both wheels with one handle.

What is the difference between the composite scissor lock and the aluminum scissor lock?

Composite scissor locks allow you to have access to the wheel lock from the side of the chair to engage them easily. The wheel lock does not retract completely under the seat when disengaged.

Aluminum scissor locks retract completely under the seat when not in use giving them the best clearance. The user of the chair must be able to reach under the seat to engage this style of lock.

What is the spoke count for the spinergy wheels offered by TiLite?

Spinergy SPOX
22″, 24″, 25″ – 18 spokes
26″ – sport hub, 24 spokes

Spinergy LX
22″, 24″, 25″ – 12 spokes
26″ – sport hub, 18 spokes

How wide is a TiLite folding chair when folded?

Permobil Serial Number Location

Once the wheels are removed the TiLite 2GX and Aero X measure about 9.5″ (24 cm) across for non-tapered frames. If you leave the wheels on, folded width will vary based on wheel type and position.

What do the numbers on the sidewall of the tire mean?

The numbers on the sidewall of the tires are the metric measurements in millimeters of the diameter and width of the tire.

Diameter
451mm = 20 inch
501mm = 22 inch
540mm = 24 inch
559mm = 25 inch
590mm = 26 inch

Permobil Serial Number 2522007128

Width
25mm = 1 inch
37mm = 1 3/8 inch
50mm = 2 inch

*We also offer a 507mm rim which is a specialty size used with the higher profile 24″ knobby tire. The tall profile of the tire makes this rim and tire combination a 24″ wheel.

What is the ergonomic seat and what does it do?

The Ergonomic Seat is a custom option available on the TiLite TR and ZR wheelchairs. It creates a bend in the rear of the seat frame that allows for little movement of the pelvis and for many people increases seated stability. This is a fixed option and should not be used for first time users or users who are not sure of their optimal seated position. If you feel this may be an option for you, you should contact a seating clinic or dealer in your area to complete a thorough assessment. To be effective, it must be combined with a wheelchair cushion that is able to conform to the shape of the frame.

Can I have a TiLite built for use with a power assist system?

All TiLite chairs are compatible with the SmartDrive Power Assist Device. For more information go to the SmartDrive page.