TEH LIN POWER SCOOTER, MODEL TL-822— 510(k) K042012

Substantially Equivalent

Teh Lin Prosthetic & Orthopaedic, Inc.

FDA 510(k) clearance K042012 for TEH LIN POWER SCOOTER, MODEL TL-822, Substantially Equivalent on 2004-09-24. Applicant: Teh Lin Prosthetic & Orthopaedic, Inc..

Clearance details

Applicant: Teh Lin Prosthetic & Orthopaedic, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2004-07-26
Decision date: 2004-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hsin Chu City, TW

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.