Electric Wheelchair— 510(k) K261396
Substantially EquivalentNingbo Resshidi Medical Devices Co., Ltd.
FDA 510(k) clearance K261396 for Electric Wheelchair, Substantially Equivalent on 2026-07-08. Applicant: Ningbo Resshidi Medical Devices Co., Ltd.. Device class: 2.
Summary
Ningbo Resshidi Medical Devices' Electric Wheelchair is filed under ITI, powered wheelchairs. The name is generic, and the record gives no model number or specs.
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 Resshidi filed from Ningbo, China. The decision came 70 calendar days after receipt (April 29 to July 8, 2026).
Clearance details
- Applicant
- Ningbo Resshidi Medical 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
- Ningbo, CN
Recent devices under product code ITI
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.