Mobility Scooter (Air Carbon)— 510(k) K260717
Substantially EquivalentSuzhou Sweetrich Vehicle Industry Technology Co., Ltd.
FDA 510(k) clearance K260717 for Mobility Scooter (Air Carbon), Substantially Equivalent on 2026-05-20. Applicant: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. Device class: 2.
Summary
Suzhou Sweetrich Vehicle Industry Technology's Mobility Scooter (Air Carbon) is filed under 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).
Sweetrich filed from Suzhou, China. The decision came 76 calendar days after receipt (March 5 to May 20, 2026).
Clearance details
- Applicant
- Suzhou Sweetrich Vehicle Industry Technology 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
- 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.