Mobility Scooter (Models: W3431D)— 510(k) K231428

Substantially Equivalent

Zhejiang Innuovo Rehabilitation Devices Co.,Ltd

FDA 510(k) clearance K231428 for Mobility Scooter (Models: W3431D), Substantially Equivalent on 2023-07-14. Applicant: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd.

Clearance details

Applicant
Zhejiang Innuovo Rehabilitation Devices Co.,Ltd
Product code
Code INI
Advisory panel
Physical Medicine
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Dongyang, CN
Download summary PDFView on FDA.gov ↗

Adverse 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.