Power Wheelchair, W5521
FDA 510(k) K231508 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
510(k) numberK231508
Submission
- Device name
- Power Wheelchair, W5521
- Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Dongyang, CN - Received
- May 25, 2023
- Decision date
- November 9, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ITI – Wheelchair, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3860
- Specialty
- Physical Medicine
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. FDA interprets mobility to persons restricted to a sitting position to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…
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| K260229 | Electric wheelchair (HC819N, HC830N, HC831N)ITI · Traditional | Yongkang Hengyi Vehicle Co., Ltd. | 09/08/2026SE |
| K260053 | Power Wheelchair (OS-R-M01I)ITI · Traditional | Beijing OrionStar Technology Co., Ltd. | 09/08/2026SE |
| K261354 | Electric wheelchair (D03)ITI · Traditional | Foshan Sowell Medical Technology Co., Ltd. | 08/21/2026SE |
| K261149 | Electric Wheelchair (DY611A-2, DY612A-1)ITI · Traditional | Zhejiang Lumbre Electric Appliance Co., Ltd. | 07/10/2026SE |
| K261396 | Electric WheelchairITI · Traditional | Ningbo Resshidi Medical Devices Co., Ltd. | 07/08/2026SE |
| K261164 | Electric wheelchair (XW-LY007 )ITI · Traditional | Yongkang Ruihe Metal Product Co., Ltd. | 07/07/2026SE |
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| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | Zhejiang Innuovo Rehabilitation Devices Co.,Ltd | 06/18/2026SE |
| K260335 | Electric Wheelchair (S500-6)ITI · Traditional | Zhongshan Sulenz Intelligent Technology Co., Ltd. | 06/15/2026SE |
| K261175 | WHILL (WHILL Model C2)ITI · Traditional | Whill, Inc. | 06/12/2026SE |
More from Whill, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260176 | Mobility Scooter (W3483, W3483A)INI · Traditional | 08/10/2026SE |
| K260094 | Mobility Scooter (W3465, W3902 (S50 Carbon))INI · Traditional | 08/10/2026SE |
| K253812 | Power Wheelchair (W5915B, W5915C, W5915D)ITI · Traditional | 06/18/2026SE |
| K260056 | Power Wheelchair (N5515A, N5516, N5517A, N5519)ITI · Traditional | 06/05/2026SE |
| K253806 | Power Wheelchair (N5919 series)ITI · Special | 04/20/2026SE |
| K242471 | Power Wheelchair (W5538)ITI · Traditional | 11/18/2024SE |
| K242387 | Mobility Scooter (N3473)INI · Traditional | 10/11/2024SE |
| K240990 | Mobility ScooterINI · Traditional | 09/10/2024SE |
| K240008 | Mobility Scooter (W3331)INI · Traditional | 06/05/2024SE |
| K240012 | Mobility Scooter (W3431)INI · Traditional | 05/02/2024SE |
Questions and answers
When was Power Wheelchair, W5521 cleared by the FDA?
Power Wheelchair, W5521 (K231508) received a 510(k) decision of Substantially Equivalent on November 9, 2023, 168 days after the submission was received.
What is the product code of K231508?
The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.