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-staging.innolitics.com/productcode/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 588)

Showing 20 most recent of 588 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260229](/device/K260229.md) | Electric wheelchair (HC819N, HC830N, HC831N) | Yongkang Hengyi Vehicle Co., Ltd. | Sep 8, 2026 | SESE |
| [K260053](/device/K260053.md) | Power Wheelchair (OS-R-M01I) | Beijing OrionStar Technology Co., Ltd. | Sep 8, 2026 | SESE |
| [K261354](/device/K261354.md) | Electric wheelchair (D03) | Foshan Sowell Medical Technology Co., Ltd. | Aug 21, 2026 | SESE |
| [K261149](/device/K261149.md) | Electric Wheelchair (DY611A-2, DY612A-1) | Zhejiang Lumbre Electric Appliance Co., Ltd. | Jul 10, 2026 | SESE |
| [K261396](/device/K261396.md) | Electric Wheelchair | Ningbo Resshidi Medical Devices Co., Ltd. | Jul 8, 2026 | SESE |
| [K261164](/device/K261164.md) | Electric wheelchair (XW-LY007 ) | Yongkang Ruihe Metal Product Co., Ltd. | Jul 7, 2026 | SESE |
| [K260937](/device/K260937.md) | Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK) | Shanghai Waylong Intelligent Technology Co.,Ltd | Jun 24, 2026 | SESE |
| [K253812](/device/K253812.md) | Power Wheelchair (W5915B, W5915C, W5915D) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Jun 18, 2026 | SESE |
| [K260335](/device/K260335.md) | Electric Wheelchair (S500-6) | Zhongshan Sulenz Intelligent Technology Co., Ltd. | Jun 15, 2026 | SESE |
| [K261175](/device/K261175.md) | WHILL (WHILL Model C2) | Whill, Inc. | Jun 12, 2026 | SESE |
| [K260056](/device/K260056.md) | Power Wheelchair (N5515A, N5516, N5517A, N5519) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Jun 5, 2026 | SESE |
| [K260373](/device/K260373.md) | Electric Wheelchair (DF506) | Jiangsu Yveelt Medical Equipment Co., Ltd. | Jun 3, 2026 | SESE |
| [K253241](/device/K253241.md) | Electric Wheelchair (Y207BL) | Jiangsu Intco Medical Products Co., Ltd. | May 13, 2026 | SESE |
| [K253806](/device/K253806.md) | Power Wheelchair (N5919 series) | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | Apr 20, 2026 | SESE |
| [K253952](/device/K253952.md) | Power Wheelchair (OS-R-M01S) | Beijing OrionStar Technology Co., Ltd. | Apr 7, 2026 | SESE |
| [K253340](/device/K253340.md) | Electric Wheelchair (AL-208S-063) | Zhongshan A&J Medical Equipment Co., Ltd. | Apr 3, 2026 | SESE |
| [K254206](/device/K254206.md) | Power wheelchair (ZS-EW8026) | Ningbo Zhishan Medical Technology Co., Ltd. | Mar 27, 2026 | SESE |
| [K253980](/device/K253980.md) | Electrically Powered Wheelchair (Model YC-01) | Yurob Rehabilitation Medical Co., Ltd. | Mar 27, 2026 | SESE |
| [K253307](/device/K253307.md) | Electric wheelchair | Foshan Dahao Medical Technology Co., Ltd. | Mar 27, 2026 | SESE |
| [K254012](/device/K254012.md) | Electric Wheelchair (E201) | Nanjing CareMoving Rehabilitation Equipment Co.,Ltd | Mar 24, 2026 | 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

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**Source:** [https://fda-staging.innolitics.com/productcode/ITI](https://fda-staging.innolitics.com/productcode/ITI)

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