SENATEK— 510(k) K822993

Substantially Equivalent

American Health Tech., Inc.

FDA 510(k) clearance K822993 for SENATEK, Substantially Equivalent on 1982-10-26. Applicant: American Health Tech., Inc..

Clearance details

Applicant: American Health Tech., Inc.
Product code: Code HST
Advisory panel: Orthopedic
Date received: 1982-10-12
Decision date: 1982-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code HST

product code HST

Other: 1
Total: 1

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.