PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT— 510(k) K011017

Name: FDA 510(k) clearance K011017
Creator: U.S. Food and Drug Administration
Published: 2001-09-24

Substantially Equivalent

Rehabilicare, Inc.

FDA 510(k) clearance K011017 for PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT, Substantially Equivalent on 2001-09-24. Applicant: Rehabilicare, Inc.. Device class: 2.

Clearance details

Applicant: Rehabilicare, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-04-04
Decision date: 2001-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brighton, MN, US

Download summary PDF View on FDA.gov ↗

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