EMPI TAPE PATCHES— 510(k) K941389

Name: FDA 510(k) clearance K941389
Creator: U.S. Food and Drug Administration
Published: 1994-08-23

Substantially Equivalent

Empi

FDA 510(k) clearance K941389 for EMPI TAPE PATCHES, Substantially Equivalent on 1994-08-23. Applicant: Empi. Device class: 1.

Clearance details

Applicant: Empi
Product code: Code KGX
Device class: Class 1
Regulation: 21 CFR 880.5240
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

Download summary PDF View on FDA.gov ↗

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K983368 — CARE BAND ANTIBACTERIAL BANDAGES1999-02-17
K972914 — SYVEK PATCH1997-12-22
K943314 — ADHESIVE BANDAGES WITH OTC DRUG1996-01-17
K952606 — TARGETT PATCH1995-12-21

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K090922 — EMPI ACTIVE TRANSCUTANEOUS NERVE STIMULATOR2009-06-05
K072946 — HYBRESIS IONTOPHORESIS DRUG DELIVERY SYSTEM2007-11-16
K070427 — DUPEL TRANSPORT IONTOPHORESIS SYSTEM2007-05-14
K061650 — SELECT TENS, MODEL 4600S2007-01-22

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.