K260176
- 510(k) number
- K260176
- Device name
- Mobility Scooter (W3483, W3483A)
- Applicant
- Zhejiang Innuovo Rehabilitation Devices Co.,Ltd CN
- Product code
- INI — Vehicle, Motorized 3-Wheeled
- Decision date
- 2026-08-10
- Date received
- 2026-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K260176
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.