Electric Wheelchair (W-A807, W-A807L)— 510(k) K253599
Substantially EquivalentNingbo Shenyu Medical Equipment Co.,Ltd
FDA 510(k) clearance K253599 for Electric Wheelchair (W-A807, W-A807L), Substantially Equivalent on 2026-02-17. Applicant: Ningbo Shenyu Medical Equipment Co.,Ltd. Device class: 2.
Summary
Ningbo Shenyu Medical Equipment's Electric Wheelchair lists two models, W-A807 and W-A807L, under product code ITI, powered wheelchair. The record doesn't say how they differ.
Class II, 21 CFR 890.3860. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Ningbo Shenyu Medical Equipment filed from Yuyao, China. Review took 91 calendar days (November 18, 2025 to February 17, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Ningbo Shenyu Medical Equipment 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
- Yuyao, CN
Recent devices under product code ITI
view allMore clearances from Ningbo Shenyu Medical Equipment 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.