PROASIA, MODEL L4501— 510(k) K052486

Substantially Equivalent

Proasia Limited

FDA 510(k) clearance K052486 for PROASIA, MODEL L4501, Substantially Equivalent on 2005-10-07. Applicant: Proasia Limited.

Clearance details

Applicant: Proasia Limited
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 2005-09-09
Decision date: 2005-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beitun District, Taichung, 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.