Components, Wheelchair
Physical Medicine · 21 CFR 890.3920
Recent MDR events
291 adverse event reports on file
- MedlineJul 28, 2026MalfunctionMedline Industries, L.p.1417592-2026-07949
- MEDLINEJul 28, 2026MalfunctionMedline Industried Lp1417592-2026-07994
- MEDLINEJul 28, 2026MalfunctionMedline Industried Lp1417592-2026-07999
- STAXIFeb 17, 2026MalfunctionStaxi Corp3008861771-2026-00001
- SMART DRIVEOct 14, 2025MalfunctionPermobil, Inc.MW5177187
- PERMOBIL SMART DRIVE SPEED CONTROL DIALSep 8, 2025MalfunctionPermobil, Inc.MW5175681
- X-CORE MAG WHEEL ASSEMBLYAug 25, 2025MalfunctionCustom Engineered Wheels (cew), Inc.MW5175147
- PERMOBIL SMART DRIVE SPEED CONTROL DIALJun 25, 2025MalfunctionPermobil, Inc.MW5171961
- SMART DRIVE WITH APPLE WATCH CONTROLLERJun 24, 2025MalfunctionPermobil, Inc.MW5171835
- SMART DRIVEJun 20, 2025InjuryPermobil, Inc.MW5171705
Event type breakdown
Recalls
11 recall events for this product code
- MUNEVO GMBHOpen, ClassifiedJul 31, 2026
munevo DRIVE and munevo DRIVE r-net
A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs, the device may experience unexpected steering drift or imprecise control while driving the wheelchair. The wheelchair may veer from its intended path, which may cause in low-speed collision, tipping, or injuries to user or bystanders.
Z-2856-2026 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedSep 2, 2025
Micro Joystick R-net. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Z-2454-2025 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedSep 2, 2025
Multi Joystick R-net. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Z-2455-2025 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedSep 2, 2025
IDM-MICRO-R. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Z-2456-2025 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedSep 2, 2025
IDM-MULTI-R. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Z-2457-2025 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedSep 2, 2025
All-round Joystick R-net Light. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Z-2458-2025 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedSep 2, 2025
IDM-ARLITE-R. Electrical wheelchair component.
Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
Z-2459-2025 · View FDA record ↗ - mo-Vis BVBAOpen, ClassifiedJan 11, 2024
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair attendant in controlling or maneuvering a power chair
In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.
Z-0713-2024 · View FDA record ↗ - Aquila CorporationOpen, ClassifiedSep 18, 2023
APK2 Pressure-Sensing Wheelchair Cushions
Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
Z-2593-2023 · View FDA record ↗ - Aquila CorporationOpen, ClassifiedSep 18, 2023
SofTech Pressure-Sensing Wheelchair Cushions
Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
Z-2594-2023 · View FDA record ↗
Registered firms
140 firms currently registered for this product code
Pride Mobility Products Corporation
North Las Vegas, NV, US
Richardson Products, Inc.
FRANKFORT, IL, US
Metalform Ltd
Dannevirke Hawke's Bay, NZ
Trolli King (holding) Ltd.
Shenzhen Guangdong, CN
Quality Life Technologies Co., Ltd.
Dongguan Guangdong, CN
Zhongshan A&j Medical Equipment Co., Ltd. (jbs)
Zhongshan City Guangdong, CN
Health Source Medical Equipment (guangdong) Ltd.
Foshan Guangdong, CN
Suzhou Sweetrich Vehicle Industry Technology Co,ltd.
Suzhou Jiangsu, CN
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.
Dongyang Zhejiang, CN
Taiwan King Strong Co., Ltd.
TAICHUNG CITY, TW
Seating Dynamics
Centennial, CO, US
Jiangsu Assure Medical Equipment Co., Ltd
ZHENJIANG CITY Jiangsu, CN
Jinhua Twinstar Tools Co. Ltd
jinhua Zhejiang, CN
Karman Healthcare Inc.
CITY OF INDUSTRY, CA, US
Valmar Surgical Supplies, Inc.
Lakewood, NJ, US
Intradin (shanghai) Machinery Co., Ltd
Shang Hai Shanghai, CN
Better Medical Technology Co., Ltd.
Foshan City Guangdong, CN
Stealth Products
BURNET, TX, US
Xiamen Taft Medical Co., Ltd.
Xiamen City Fujian, CN
Mbl Poland Sp. Z O.o.
Piotrkow Trybunalski Lodzkie, PL
Roho, Inc.
Belleville, IL, US
Jiangsu Andycare Medical Products Co.,ltd.
Zhenjiang Jiangsu, CN
Avivo Life, Llc
Rockville, MD, US
Danyang Sunco Machinery Co., Ltd.
Danyang City Jiangsu, CN
Dynamic Connect (suzhou) Hi-tech Electronics Co. Ltd.
Jiangsu, CN
510(k) clearances
64 clearances for this product code
- Kinetic Innovative Seating System, LLCMar 4, 2022
K211919 · KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
- Foley & LardnerNov 7, 1994
K942309 · DYNASTY U1-31 (GELL/CELL)
- Foley & LardnerNov 7, 1994
K942310 · DYNASTY GC 12550 (GELL/CELL)
- Foley & LardnerNov 7, 1994
K942308 · DYNASTY GC 12400 (GELL/CELL)
- Foley & LardnerNov 7, 1994
K942311 · DYNASTY U1-33 AGM
- Ward and Assoc.May 26, 1994
K942260 · ALDEN WHEELCHAIR CUSHION
- Lewis W. WardMay 26, 1994
K942312 · ALDEN LINEAGE WHEELCHAIR CUSHION
- General Components Intl., Inc.Oct 12, 1993
K933051 · ZERO GRAVITY WHEELCHAIR COMPONENTS, MODIFICATION