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Panels › Physical Medicine › Product code IOR · Class 1

Wheelchair, Mechanical

Regulation 890.3850

21510(k)s in 12 months (468 all time)
0recalls in 12 months (40 all time)
31recalls that name a 510(k)
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Top companies in IOR

Company510(k)sRecalls
Invacare Corp.327
Colours 'N Motion120
Freedom Designs, Inc.101
Sunrise Medical91
Zhenjiang Assure Medical Equipment Co., Ltd.100
Everest & Jennings, Inc.90
Pdg Product Design Group, Inc.81
Sunrise Medical (Us), LLC18
Tisport53
Gunnell, Inc.15
Decided510(k)Device and applicantCode
Sep 22, 2026K253762ErgoSteel (ES0001/696)
Strongback Mobility AG C/O Blueaudit GmbH, CH
IOR
Sep 16, 2026K261919Multifunctional wheelchair (YJ-059)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2026K260145YJ-K1K2 Wheelchair (YJ-013F)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2026K260144Reclining wheelchair (YJ-013L)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2026K260141Bariatric Heavy Duty Wheelchair (YJ-010V, YJ-010C)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Aug 6, 2026K261571Manual Wheelchair (H008, PCK7)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd., CN
IOR
Jul 24, 2026K252370GEN 4 JOY Wheelchair
Free Wheelchair Mission
IOR
Jun 22, 2026K261076Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02)
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd., CN
IOR
Jun 22, 2026K261075Manual Wheelchair (MS01);Manual Wheelchair (MA01)
GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd., CN
IOR
Jun 11, 2026K260849ICON 35; ICON 45; ICON 60; ICON 30FAF
Rehasense USA, Inc.
IOR
Jun 2, 2026K260642Manual Wheelchair (LW01108)
Anhui Longway Medical Technology Co., Ltd., CN
IOR
May 28, 2026K260295Helio Kids; Apex P
Motion Composites, CA
IOR
May 21, 2026K254141Manual Wheelchair (DY01903(2))
Guangdong Dayang Medical Technology Co., Ltd., CN
IOR
Apr 28, 2026K260121Manual Wheelchair (7101L, 7102LHD)
Foshan Nanhai Hongchen Medical Equipment Co., Ltd., CN
IOR
Mar 31, 2026K260319K5 wheelchair (16” with swing-away footrest 18” with swing-away footrest 20” with swing-away footrest 16” with elevated
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Jan 29, 2026K253632Manual Wheelchair (W50)
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd., CN
IOR
Jan 12, 2026K251886EmpowerRide NAVIGATOR
Empower Ride, LLC
IOR
Dec 5, 2025K252828Manual Wheelchair (W47)
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd., CN
IOR
Dec 5, 2025K252825Manual Wheelchair (W45)
Jiangsu Jumao X-Care Medical Equipment Co., , Ltd., CN
IOR
Nov 21, 2025K252687Manual Wheelchair (HM305-Air1, HM305-Air2)
Suzhou Master Machinery Manufacturing Co.,Ltd, CN
IOR
Nov 4, 2025K250576Flexx Junior (FLX-J00, FLX-J50)
Karma Mobility Co, Ltd., TH
IOR
Oct 3, 2025K252517Manual Wheelchair (SYIV100A008)
Ningbo Shenyu Medical Equipment Co.,Ltd, CN
IOR
Feb 28, 2025K241374Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009)
Anhui Jbh Medical Apparatus Co., Ltd., CN
IOR
Jan 10, 2025K243111Bowhead ERA Wheelchairs
Bowhead Design Corp., CA
IOR
Nov 22, 2024K242722Manual Wheelchair (MASY23)
Sichuan Ast Medical Equipment Co., Ltd., CN
IOR
Oct 24, 2024K242560Manual Wheelchair (SYIV100-CA9221)
Foshan Shunkangda Medical Tech Co., Ltd., CN
IOR
Jul 11, 2024K241460Manual Wheelchair
Lichtmega Technology Co., Ltd., CN
IOR
Jul 5, 2024K240120Merlexi Craft Bariatric series of manual wheelchairs
Turbo Wheelchair Co., Inc.
IOR
Oct 3, 2023K232230YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE; YJ-K1F 16 NDS; YJ-K1F 18 NDE; YJ-K1F 18 NDS; YJ-K1F 20 NDE; YJ-K1F 20 NDS; YJ-K1F 18
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2023K232199Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-01
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 15, 2023K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Sep 5, 2023K200583Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL
Ki Mobility, LLC
IOR
Aug 31, 2023K223527Little Wave Clik, Rogue XP, Little Wave XP, Spark
Ki Mobility, LLC
IOR
Aug 15, 2023K231750MA012 Aluminum wheelchair, MS019 steel wheelchair
Sichuan Ast Medical Equipment Co., Ltd., CN
IOR
Jun 16, 2023K231110Manual Wheelchair (A006)
Ningbo Shenyu Medical Equipment Co.,Ltd, CN
IOR
Jun 5, 2023K231320Zhenjiang Assure Mechanical Wheelchair,model:K1
Zhenjiang Assure Medical Equipment Co., Ltd., CN
IOR
Feb 16, 2023K220698Bambino 3, S3 and S3 Swing, U3 and U3 Light, X
Panthera AB, SE
IOR
Oct 28, 2022K221435SUPERTILT PLUS (STP)
Power Plus Mobility, CA
IOR
Jul 21, 2022K220671Manual Wheelchair
Hebei Ruilangde Medical Equipment Technology Group Co., Ltd., CN
IOR
Jun 24, 2022K200715RoughRider Aurora Manual Wheelchair
Roughrider America, LLC
IOR
Mar 14, 2022K213790Aluminum back folding wheelchair SYIV 100-LQXAL2482-407
Mobility Source Medical Technology Co., Ltd., CN
IOR
Jun 14, 2021K200466Manual Wheelchair (Model W28)
Jiangsu Jumao X-Care Medical Equipment Co., Ltd., CN
IOR
May 21, 2021K201461Manual Wheelchair, Model A011
Ningbo Shenyu Medical Equipment Co.,Ltd, CN
IOR
Sep 10, 2020K200135RGK Daily Range Wheelchairs
Rgk Wheelchairs, Ltd., GB
IOR
Apr 1, 2020K192658Manual Wheelchair
Jerry Medical Instrument (Shanghai) Co., Ltd., CN
IOR
Jul 1, 2019K190550IKON 40 Manual Wheelchair
Broda Seating (Broda Lp), CA
IOR
May 29, 2019K190534Manual Wheelchair SIVFH2A102
Jiangsu Horizon Medical Science & Technology Co., Ltd., CN
IOR
May 9, 2019K190699Rowheels Revolution 1.0
Rowheels, Inc.
IOR
May 3, 2019K180309Manual Wheelchair W54
Jiangsu Jumao Medical Equipment Co., Ltd., CN
IOR
Apr 29, 2019K182840Element Pediatric Wheelchair
Leggero, LLC
IOR

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