ECOGEL 300 TENS GEL— 510(k) K962681

Name: FDA 510(k) clearance K962681
Creator: U.S. Food and Drug Administration
Published: 1996-10-04

Substantially Equivalent

Eco-Med Pharmaceuticals, Inc.

FDA 510(k) clearance K962681 for ECOGEL 300 TENS GEL, Substantially Equivalent on 1996-10-04. Applicant: Eco-Med Pharmaceuticals, Inc.. Device class: 2.

Clearance details

Applicant: Eco-Med Pharmaceuticals, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1996-07-10
Decision date: 1996-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, Ontario, CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K962681

K-number listed on FDA's recall record

Z-0068-2022 — ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser BtlClass I·Ongoing·National Distribution & Contracting Inc·20210824

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962681.

Data sourced from openFDA. This site is unofficial and independent of the FDA.