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 890.3860](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3860) → ITI — Wheelchair, Powered # ITI · Wheelchair, Powered _Physical Medicine · 21 CFR 890.3860 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI ## Overview - **Product Code:** ITI - **Device Name:** Wheelchair, Powered - **Regulation:** [21 CFR 890.3860](/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/890.3860) - **Device Class:** 2 - **Review Panel:** [Physical Medicine](/submissions/PM) - **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](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253806.md) | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Apr 20, 2026 | SESE | | [K253952](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253952.md) | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | Apr 7, 2026 | SESE | | [K253340](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253340.md) | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | Apr 3, 2026 | SESE | | [K254206](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K254206.md) | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | Mar 27, 2026 | SESE | | [K253980](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253980.md) | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | Mar 27, 2026 | SESE | | [K253307](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253307.md) | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | Mar 27, 2026 | SESE | | [K254012](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K254012.md) | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | Mar 24, 2026 | SESE | | [K253849](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253849.md) | Electric wheelchair (JJW-7002, JJW-7003) | ZheJiang J&J Mobility Co., Ltd. | Mar 20, 2026 | SESE | | [K252101](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K252101.md) | JWG-1 | Yamaha Motor Co., Ltd. | Mar 19, 2026 | SESE | | [K253870](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253870.md) | Electric Wheelchair (MP148) | Suzhou Master Machinery Manufacturing Co.,Ltd | Mar 4, 2026 | SESE | | [K253789](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253789.md) | Electric wheelchair | Zhejiang Yikang Medical Technology Co., Ltd. | Feb 25, 2026 | SESE | | [K253707](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253707.md) | Electric wheelchair (W1,W3) | Shenzhen Zhimahuaerkai Technology Co., Ltd. | Feb 24, 2026 | SESE | | [K253599](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253599.md) | Electric Wheelchair (W-A807, W-A807L) | Ningbo Shenyu Medical Equipment Co.,Ltd | Feb 17, 2026 | SESE | | [K253276](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K253276.md) | Electric Wheelchair (Robooter E80) (BBR-E80-01); Electric Wheelchair (Robooter E80) (BBR-E80-02) | Shanghai Bangbang Robotics Co., Ltd. | Jan 15, 2026 | SESE | | [K251458](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K251458.md) | Electric Wheelchair (DH01168) | Foshan Dahao Medical Technology Co., Ltd. | Jan 15, 2026 | SESE | | [K251159](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K251159.md) | Power wheelchair | Zhenjiang Assure Medical Equipment Co., Ltd. | Dec 22, 2025 | SESE | | [K252862](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K252862.md) | Electric Wheelchair (DH01126) | Foshan Dahao Medical Technology Co., Ltd. | Dec 8, 2025 | SESE | | [K252494](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K252494.md) | Electrically powered wheelchair (KZ301B) | Nanjing Kangni Smart Technology Co., Ltd. | Dec 5, 2025 | SESE | | [K252829](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K252829.md) | Powered Wheelchair (PL001-9001) | Suzhou KD Intelligent Device Co., Ltd. | Nov 12, 2025 | SESE | | [K250819](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI/K250819.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI](https://fda.innolitics.com/submissions/PM/subpart-d%E2%80%94physical-medicine-prosthetic-devices/ITI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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