ITI · Wheelchair, Powered
Physical Medicine · 21 CFR 890.3860 · Class 2
Overview
| Product Code | ITI |
|---|---|
| Device Name | Wheelchair, Powered |
| Regulation | 21 CFR 890.3860 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 575)
Showing 20 most recent of 575 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253806 | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Apr 20, 2026 | SESE |
| K253952 | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | Apr 7, 2026 | SESE |
| K253340 | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | Apr 3, 2026 | SESE |
| K254206 | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | Mar 27, 2026 | SESE |
| K253980 | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | Mar 27, 2026 | SESE |
| K253307 | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | Mar 27, 2026 | SESE |
| K254012 | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | Mar 24, 2026 | SESE |
| K253849 | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | Mar 20, 2026 | SESE |
| K252101 | JWG-1 | Yamaha Motor Co., Ltd. | Mar 19, 2026 | SESE |
| K253870 | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd | Mar 4, 2026 | SESE |
| K253789 | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | Feb 25, 2026 | SESE |
| K253707 | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Feb 24, 2026 | SESE |
| K253599 | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd | Feb 17, 2026 | SESE |
| K253276 | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. | Jan 15, 2026 | SESE |
| K251458 | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. | Jan 15, 2026 | SESE |
| K251159 | Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | Dec 22, 2025 | SESE |
| K252862 | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. | Dec 8, 2025 | SESE |
| K252494 | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. | Dec 5, 2025 | SESE |
| K252829 | Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. | Nov 12, 2025 | SESE |
| K250819 | Electric Wheelchair (Rollz Motion Electric 2M) | Rollz International BV | Nov 7, 2025 | SESE |
Top Applicants
- Invacare Corp. — 32 clearances
- Fortress Scientific , Ltd. — 19 clearances
- Everest & Jennings, Inc. — 17 clearances
- Hoveround Corp. — 15 clearances
- Permobil AB — 11 clearances
