Solax Electric Scooter (Models: S204311M, S204161, S204143)— 510(k) K190737

Substantially Equivalent

Dongguan Prestige Sporting Goods Co., Ltd.

FDA 510(k) clearance K190737 for Solax Electric Scooter (Models: S204311M, S204161, S204143), Substantially Equivalent on 2021-05-10. Applicant: Dongguan Prestige Sporting Goods Co., Ltd..

Clearance details

Applicant: Dongguan Prestige Sporting Goods Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2019-03-22
Decision date: 2021-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

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.