Scooter (Model: FDB01)— 510(k) K201196

Substantially Equivalent

Nanjing Jin Bai HE Medical Apparatus Co., Ltd.

FDA 510(k) clearance K201196 for Scooter (Model: FDB01), Substantially Equivalent on 2021-06-25. Applicant: Nanjing Jin Bai HE Medical Apparatus Co., Ltd..

Clearance details

Applicant: Nanjing Jin Bai HE Medical Apparatus Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2020-05-04
Decision date: 2021-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nanjing, 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.