ALPHA CONDOR— 510(k) K893429

Substantially Equivalent

Alpha Unlimited, Inc.

FDA 510(k) clearance K893429 for ALPHA CONDOR, Substantially Equivalent on 1989-06-12. Applicant: Alpha Unlimited, Inc..

Clearance details

Applicant: Alpha Unlimited, Inc.
Product code: Code INI
Advisory panel: Physical Medicine
Date received: 1989-05-02
Decision date: 1989-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, US

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.