TENS-O-MATIC— 510(k) K811012

Substantially Equivalent

O-Matic, Inc.

FDA 510(k) clearance K811012 for TENS-O-MATIC, Substantially Equivalent on 1981-06-01. Applicant: O-Matic, Inc.. Device class: 2.

Clearance details

Applicant: O-Matic, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1981-04-15
Decision date: 1981-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.