Accessories, Wheelchair
Physical Medicine · 21 CFR 890.3910
Recent MDR events
63 adverse event reports on file
- THE COMFORT COMPANIESJul 10, 2026InjuryThe Comfort Companies Llc3009875802-2026-00002
- MEDLINEJul 10, 2026MalfunctionMedline Industries, Lp1417592-2026-05079
- BUDDYBUTTONMay 4, 2026InjuryAblenet, Inc.MW5187605
- COMFORT M2 CUSHIONJan 9, 2026MalfunctionThe Comfort Companies, L.l.c.2135139-2025-00004
- ACCESSORIES, WHEELCHAIRDec 29, 2025MalfunctionPryor ProductsMW5181232
- COMFORT M2 CUSHIONJul 2, 2025InjuryThe Comfort Companies, L.l.c.2135139-2025-00003
- UNKNOWNJun 25, 2025DeathUnknown1525712-2025-00009
- COMFORT ARMMar 6, 2025InjuryThe Comfort Companies, L.l.c.2135139-2025-00002
- ACCESSORIES, WHEELCHAIRFeb 6, 2025InjuryMedline Industries, Lp - NorthfieldMW5165698
- COMFORT M2 CUSHIONJan 17, 2025InjuryThe Comfort Companies, L.l.c.2135139-2025-00001
Event type breakdown
Recalls
3 recall events for this product code
- Action Products IncorporatedTerminatedJul 20, 2004
Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop seat Base Wheelchair cushions.
Wheelchair seat may not properly support the user due to cracks in the plastic seat base.
Z-0709-04 · View FDA record ↗ - Action Products IncorporatedTerminatedDec 5, 2002
Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with Integrated Drop Seat wheelchairs, model/item numbers 05D, 1
Wheelchair seat component is defective.
Z-316/318-3 · View FDA record ↗ - Merits Holdings Co. dba Merits Health Products, Inc.TerminatedUnknown
Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs.
Pinion gear may disengage from track allowing lift to slip or jolt.
Z-1632-2020 · View FDA record ↗
Registered firms
222 firms currently registered for this product code
Gentry Way Co., Ltd.
Tainan City, TW
Jiangsu Andycare Medical Products Co.,ltd.
Zhenjiang Jiangsu, CN
Care&care Health Products Co., Ltd
Yuanli Township Miaoli, TW
Fortune Company Ltd.
Huizhou Guangdong, CN
Top Longmax Products Co., Ltd.
TAICHUNG, TW
Sunrise Medical (us) Llc
FRESNO, CA, US
Jan Mao Industries Co., Ltd.
Baise City Guangxi, CN
Otto Bock Mobility Solutions Gmbh
Koenigsee Thuringia, DE
Adaptive Switch Laboratories, Inc.
SPICEWOOD, TX, US
Pride Mobility Products Corporation
North Las Vegas, NV, US
Guangdong Hexin Technology Weaving Co., Ltd
Huizhou City Guangdong, CN
Synetik Group Inc.
Joliette Quebec, CA
Jiangsu Assure Medical Equipment Co., Ltd
ZHENJIANG CITY Jiangsu, CN
Motion Concepts Lp
Vaughan Ontario, CA
Foshan Maiteng Medical Technology Co., Ltd
Foshan Guangdong, CN
Luci Mobility, Inc.
Wheat Ridge, CO, US
Jiangsu Yongxin Medical Equipment Co., Ltd
ZHANGJIAGANG Jiangsu, CN
Headovations, Ltd.
Tel Aviv Central, IL
Xinhao Rehabilitation Equipment Company Limited
Thu Dau Mot Binh Duong, VN
Xi'an Centeringone International Trading & Consultants Ltd.
Xi'an Shaanxi, CN
Ortho Pauher Ind. Com. E Dist. Ltda
Recife Pernambuco, BR
Jiayi Company Limited
DUC HOA COMMUNE Tay Ninh, VN
Mass Corporation
Apia Tuamasaga, WS
Prentke Romich Co.
WOOSTER, OH, US
Ki Mobility
Stevens Point, WI, US
510(k) clearances
35 clearances for this product code
- Redman, Inc.Feb 26, 1987
K870298 · REDMAN ACCESSORIES
- Fred Sammons, Inc.Jan 21, 1983
K823646 · FRICTION FEEDER
- Fred Sammons, Inc.Jan 21, 1983
K823645 · VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR
- Danek Medical, Inc.Jan 14, 1983
K823816 · WHEELCHAIR PATIENT RESTRAINTS
- Fred Sammons, Inc.Dec 28, 1982
K823636 · ARM THROUGH FOR WHEELCHAIR BK-6459-01 &
- Fred Sammons, Inc.Dec 28, 1982
K823635 · CUSHIONS FOR WHEELCHAIR ARMS
- Fred Sammons, Inc.Dec 22, 1982
K823596 · CLAMP ON HOLDER FOR A GLASS OR CUP
- Fred Sammons, Inc.Dec 22, 1982
K823595 · HEAD SUPPORT FOR WHEELCHAIR