Browse hierarchy: [Physical Medicine (PM)](/submissions/PM) → [Subpart D — Physical Medicine Prosthetic Devices](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices) → [21 CFR 890.3850](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3850) → IOR — Wheelchair, Mechanical

# IOR · Wheelchair, Mechanical

_Physical Medicine · 21 CFR 890.3850 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR

## Overview

- **Product Code:** IOR
- **Device Name:** Wheelchair, Mechanical
- **Regulation:** [21 CFR 890.3850](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3850)
- **Device Class:** 1
- **Review Panel:** [Physical Medicine](/submissions/PM)
- **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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K260319.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K253632.md) | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Jan 29, 2026 | SESE |
| [K251886](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K251886.md) | EmpowerRide NAVIGATOR | Empower Ride, LLC | Jan 12, 2026 | SESE |
| [K252828](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K252828.md) | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Dec 5, 2025 | SESE |
| [K252825](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K252825.md) | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Dec 5, 2025 | SESE |
| [K252687](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K252687.md) | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | Nov 21, 2025 | SESE |
| [K250576](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K250576.md) | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | Nov 4, 2025 | SESE |
| [K252517](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K252517.md) | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | Oct 3, 2025 | SESE |
| [K241374](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K241374.md) | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | Feb 28, 2025 | SESE |
| [K243111](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K243111.md) | Bowhead ERA Wheelchairs | Bowhead Design Corp. | Jan 10, 2025 | SESE |
| [K242722](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K242722.md) | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | Nov 22, 2024 | SESE |
| [K242560](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K242560.md) | Manual Wheelchair (SYIV100-CA9221) | Foshan Shunkangda Medical Tech Co., Ltd. | Oct 24, 2024 | SESE |
| [K241460](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K241460.md) | Manual Wheelchair | Lichtmega Technology Co., Ltd. | Jul 11, 2024 | SESE |
| [K240120](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K240120.md) | Merlexi Craft Bariatric series of manual wheelchairs | Turbo Wheelchair Co., Inc. | Jul 5, 2024 | SESE |
| [K232230](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K232230.md) | 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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K232199.md) | Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS; YJ-010B 20’’DE; YJ-010B 20’’DFS; YJ-010B 20’’DFE;YJ-010B 20’’ADS; YJ-010B 20’’ADE; YJ-010B 20’’ADFS; YJ-010B 20’’ADFE; YJ-010B 22’’DS; YJ-010B 22’’DE; YJ-010B 22’’DFS;YJ-010B 22’’DFE; YJ-010B 22’’ADS;YJ-010B 22’’ADE; YJ-010B 22’’ADFS; YJ-010B 22’’ADFE; YJ-010B 24’’DS; YJ-010B 24’’DE; YJ-010B 24’’DFS; YJ-010B 24’’DFE; YJ-010B 24’’ADS; YJ-010B 24’’ADE; YJ-010B 22’’ADFS; YJ-010B 24’’ADFE) | Zhenjiang Assure Medical Equipment Co., Ltd. | Sep 15, 2023 | SESE |
| [K232198](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K232198.md) | Reclining 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. | Sep 15, 2023 | SESE |
| [K200583](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K200583.md) | Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL | Ki Mobility, LLC | Sep 5, 2023 | SESE |
| [K223527](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K223527.md) | Little Wave Clik, Rogue XP, Little Wave XP, Spark | Ki Mobility, LLC | Aug 31, 2023 | SESE |
| [K231750](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR/K231750.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/IOR)

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