EMPI TAPE PATCHES— 510(k) K941389

Substantially Equivalent

Empi

FDA 510(k) clearance K941389 for EMPI TAPE PATCHES, Substantially Equivalent on 1994-08-23. Applicant: Empi.

Clearance details

Applicant: Empi
Product code: Code KGX
Advisory panel: General Hospital
Date received: 1994-03-22
Decision date: 1994-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arden Hills, MN, US

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Adverse events under product code KGX

product code KGX

Injury: 1,590
Malfunction: 1,357
Other: 3
Total: 2,950

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.