Power Wheelchair (W5915B, W5915C, W5915D)— 510(k) K253812
Substantially EquivalentZhejiang Innuovo Rehabilitation Devices Co.,Ltd
FDA 510(k) clearance K253812 for Power Wheelchair (W5915B, W5915C, W5915D), Substantially Equivalent on 2026-06-18. Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Device class: 2.
Summary
Zhejiang Innuovo Rehabilitation Devices' Power Wheelchair is listed in three models, W5915B, W5915C, and W5915D. It's filed under ITI, powered wheelchairs, and the record doesn't say how the models differ.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Innuovo filed from Dongyang, China. The decision came 202 calendar days after FDA received it (November 28, 2025 to June 18, 2026).
Clearance details
- Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
- Product code
- Product code ITI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3860
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongyang, CN
Recent devices under product code ITI
view allMore clearances from Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
view allAdverse events under product code ITI
product code ITI- Death
- 34
- Injury
- 778
- Malfunction
- 1,085
- Other
- 1
- Total
- 1,898
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.