K253075

Substantially Equivalent

Mobility scooter (Air Classic); Mobility scooter (Air Traveller); Mobility scooter (Air Traveller2.0)

Applicant: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.
Product code: INI
Advisory panel: Physical Medicine
Date received: 2025-09-23
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Adverse events under product code INI

product code INI

Injury: 171
Other: 1
Total: 172

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.