SIMPLEX TENS— 510(k) K953982

Substantially Equivalent

Armstrong Industries, Inc.

FDA 510(k) clearance K953982 for SIMPLEX TENS, Substantially Equivalent on 1997-04-25. Applicant: Armstrong Industries, Inc.. Device class: 2.

Clearance details

Applicant: Armstrong Industries, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1995-08-23
Decision date: 1997-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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