Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140)— 510(k) K232692

Substantially Equivalent

Intradin (Shanghai) Machinery Co., Ltd.

FDA 510(k) clearance K232692 for Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140), Substantially Equivalent on 2024-09-05. Applicant: Intradin (Shanghai) Machinery Co., Ltd..

Clearance details

Applicant: Intradin (Shanghai) Machinery Co., Ltd.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2023-09-05
Decision date: 2024-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, 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.