Power Wheelchair (N5919 series)— 510(k) K253806
Substantially EquivalentZhejiang Innuovo Rehabilitation Devices Co.,Ltd
FDA 510(k) clearance K253806 for Power Wheelchair (N5919 series), Substantially Equivalent on 2026-04-20. Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Device class: 2.
Summary
Zhejiang Innuovo Rehabilitation Devices' Power Wheelchair (N5919 series) is filed under product code ITI (Wheelchair, Powered). The record doesn't describe the wheelchair beyond its name and that code name.
Class II, 21 CFR 890.3860. It came in as a Special 510(k), and Physical Medicine is both the classification panel and the review panel.
Zhejiang Innuovo Rehabilitation Devices filed from Dongyang, China. Review took 143 calendar days (November 28, 2025 to April 20, 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
- Special
- 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.