Mobility scooter (3 models)— 510(k) K253075
Substantially EquivalentSuzhou Sweetrich Vehicle Industry Technology Co., Ltd.
FDA 510(k) clearance K253075 for Mobility scooter (3 models), Substantially Equivalent on 2026-01-09. Applicant: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. Device class: 2.
Clearance details
- Device name as filed
- Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)
- Applicant
- Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
- Product code
- 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
- Suzhou, CN
Recent devices under product code INI
view allMore clearances from Suzhou Sweetrich Vehicle Industry Technology 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.