TENS-IT, FITTRONIC II, (MORE LATER)— 510(k) K946018

Substantially Equivalent

Ems, Inc.

FDA 510(k) clearance K946018 for TENS-IT, FITTRONIC II, (MORE LATER), Substantially Equivalent on 1995-11-09. Applicant: Ems, Inc.. Device class: 2.

Clearance details

Applicant: Ems, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 1994-12-09
Decision date: 1995-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pen Valley, CA, US

Download summary PDF View on FDA.gov ↗

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