IOR · Wheelchair, Mechanical
Physical Medicine · 21 CFR 890.3850 · Class 1
Overview
| Product Code | IOR |
|---|---|
| Device Name | Wheelchair, Mechanical |
| Regulation | 21 CFR 890.3850 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (20 of 454)
Showing 20 most recent of 454 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260319 | K5 wheelchair (16 with swing-away footrest 18 with swing-away footrest 20 with swing-away footrest 16 with elevated foot rest(ELR) 18 with elevated foot rest(ELR) 20 with elevated foot rest(ELR)) | Zhenjiang Assure Medical Equipment Co., Ltd. | Mar 31, 2026 | SESE |
| K253632 | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Jan 29, 2026 | SESE |
| K251886 | EmpowerRide NAVIGATOR | Empower Ride, LLC | Jan 12, 2026 | SESE |
| K252828 | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Dec 5, 2025 | SESE |
| K252825 | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Dec 5, 2025 | SESE |
| K252687 | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | Nov 21, 2025 | SESE |
| K250576 | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | Nov 4, 2025 | SESE |
| K252517 | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | Oct 3, 2025 | SESE |
| K241374 | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | Feb 28, 2025 | SESE |
| K243111 | Bowhead ERA Wheelchairs | Bowhead Design Corp. | Jan 10, 2025 | SESE |
| K242722 | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | Nov 22, 2024 | SESE |
| K242560 | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | Oct 24, 2024 | SESE |
| K241460 | Manual Wheelchair | Lichtmega Technology Co., Ltd. | Jul 11, 2024 | SESE |
| K240120 | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | Jul 5, 2024 | SESE |
| K232230 | YJ-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 NDEE; YJ-K1F 16 VDE; YJ-K1F 16 VDS; YJ-K1F 18 VDE; YJ-K1F 18 VDS; YJ-K1F 20 VDE; YJ-K1F 20 VDS; YJ-K2 16 VDFE; YJ-K2 16 VDFS; YJ-K2 18 VDFE; YJ-K2 18 VDFS; YJ-K2 20 VDFE; YJ-K2 20 VDFS; YJ-K1G 18 NFFE; YJ-K1G 18 NFFS; YJ-K2TC 16 NAFE; YJ-K2TC 18 NAFE; YJ-K2TC 20 NAFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | Oct 3, 2023 | SESE |
| K232199 | Bariatric Heavy Duty Wheelchair (YJ-010B 20DS; YJ-010B 20DE; YJ-010B 20DFS; YJ-010B 20DFE;YJ-010B 20ADS; YJ-010B 20ADE; YJ-010B 20ADFS; YJ-010B 20ADFE; YJ-010B 22DS; YJ-010B 22DE; YJ-010B 22DFS;YJ-010B 22DFE; YJ-010B 22ADS;YJ-010B 22ADE; YJ-010B 22ADFS; YJ-010B 22ADFE; YJ-010B 24DS; YJ-010B 24DE; YJ-010B 24DFS; YJ-010B 24DFE; YJ-010B 24ADS; YJ-010B 24ADE; YJ-010B 22ADFS; YJ-010B 24ADFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | Sep 15, 2023 | SESE |
| K232198 | Reclining wheelchair (YJ-011S 16D, YJ-011S 16DF, YJ-011S 18D, YJ-011S 18DF, YJ-011S 20D, YJ-011S 20DF) | Zhenjiang Assure Medical Equipment Co., Ltd. | Sep 15, 2023 | SESE |
| K200583 | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC | Sep 5, 2023 | SESE |
| K223527 | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | Aug 31, 2023 | SESE |
| K231750 | MA012 Aluminum wheelchair, MS019 steel wheelchair | Sichuan Ast Medical Equipment Co., Ltd. | Aug 15, 2023 | SESE |
Top Applicants
- Invacare Corp. — 24 clearances
- Colours 'N Motion — 12 clearances
- Freedom Designs, Inc. — 10 clearances
- Everest & Jennings, Inc. — 9 clearances
- Invacare Corporation — 8 clearances
