Mobility Scooter (W3483, W3483A)— 510(k) K260176
Substantially EquivalentZhejiang Innuovo Rehabilitation Devices Co.,Ltd
FDA 510(k) clearance K260176 for Mobility Scooter (W3483, W3483A), Substantially Equivalent on 2026-08-10. Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Device class: 2.
Summary
Zhejiang Innuovo Rehabilitation Devices' Mobility Scooter in this record lists models W3483 and W3483A. It's filed under product code INI, motorized 3-wheeled vehicles.
Class II, 21 CFR 890.3800. Physical Medicine is both the classification panel and the review panel. The submission was a Traditional 510(k).
Innuovo filed from Dongyang, China. FDA found it substantially equivalent 201 calendar days after receipt (January 21 to August 10, 2026).
Clearance details
- Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
- Product code
- Product code INI
- Device class
- Class 2
- Regulation
- 21 CFR 890.3800
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongyang, CN
Recent devices under product code INI
view allMore clearances from Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
view allAdverse events under product code INI
product code INI- Injury
- 171
- Other
- 1
- Total
- 172
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.