THERAPIK— 510(k) K964397

Substantially Equivalent

The Jenex Corporation

FDA 510(k) clearance K964397 for THERAPIK, Substantially Equivalent on 1997-11-04. Applicant: The Jenex Corporation.

Clearance details

Applicant: The Jenex Corporation
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 1996-11-04
Decision date: 1997-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pawtucket, RI, US

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.