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-staging.innolitics.com/productcode/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 463)

Showing 20 most recent of 463 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K261571](/device/K261571.md) | Manual Wheelchair (H008, PCK7) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | Aug 6, 2026 | SESE |
| [K252370](/device/K252370.md) | GEN 4 JOY Wheelchair | Free Wheelchair Mission | Jul 24, 2026 | SESE |
| [K261076](/device/K261076.md) | Caregiver-assisted wheelchair (MS02);Caregiver-assisted wheelchair (MA02) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | Jun 22, 2026 | SESE |
| [K261075](/device/K261075.md) | Manual Wheelchair (MS01);Manual Wheelchair (MA01) | GuangDong Yong Yi Rehabilitation Equipment Technology Co., Ltd. | Jun 22, 2026 | SESE |
| [K260849](/device/K260849.md) | ICON 35; ICON 45; ICON 60; ICON 30FAF | Rehasense USA, Inc. | Jun 11, 2026 | SESE |
| [K260642](/device/K260642.md) | Manual Wheelchair (LW01108) | Anhui Longway Medical Technology Co., Ltd. | Jun 2, 2026 | SESE |
| [K260295](/device/K260295.md) | Helio Kids; Apex P | Motion Composites | May 28, 2026 | SESE |
| [K254141](/device/K254141.md) | Manual Wheelchair (DY01903(2)) | Guangdong Dayang Medical Technology Co., Ltd. | May 21, 2026 | SESE |
| [K260121](/device/K260121.md) | Manual Wheelchair (7101L, 7102LHD) | Foshan Nanhai Hongchen Medical Equipment Co., Ltd. | Apr 28, 2026 | SESE |
| [K260319](/device/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](/device/K253632.md) | Manual Wheelchair (W50) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Jan 29, 2026 | SESE |
| [K251886](/device/K251886.md) | EmpowerRide NAVIGATOR | Empower Ride, LLC | Jan 12, 2026 | SESE |
| [K252828](/device/K252828.md) | Manual Wheelchair (W47) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Dec 5, 2025 | SESE |
| [K252825](/device/K252825.md) | Manual Wheelchair (W45) | Jiangsu Jumao X-Care Medical Equipment Co., , Ltd. | Dec 5, 2025 | SESE |
| [K252687](/device/K252687.md) | Manual Wheelchair (HM305-Air1, HM305-Air2) | Suzhou Master Machinery Manufacturing Co.,Ltd | Nov 21, 2025 | SESE |
| [K250576](/device/K250576.md) | Flexx Junior (FLX-J00, FLX-J50) | Karma Mobility Co, Ltd. | Nov 4, 2025 | SESE |
| [K252517](/device/K252517.md) | Manual Wheelchair (SYIV100A008) | Ningbo Shenyu Medical Equipment Co.,Ltd | Oct 3, 2025 | SESE |
| [K241374](/device/K241374.md) | Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) | Anhui Jbh Medical Apparatus Co., Ltd. | Feb 28, 2025 | SESE |
| [K243111](/device/K243111.md) | Bowhead ERA Wheelchairs | Bowhead Design Corp. | Jan 10, 2025 | SESE |
| [K242722](/device/K242722.md) | Manual Wheelchair (MASY23) | Sichuan Ast Medical Equipment Co., Ltd. | Nov 22, 2024 | 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-staging.innolitics.com/productcode/IOR](https://fda-staging.innolitics.com/productcode/IOR)

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