MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC— 510(k) K022405

Name: FDA 510(k) clearance K022405
Creator: U.S. Food and Drug Administration
Published: 2002-08-12

Substantially Equivalent

Rehabilicare, Inc.

FDA 510(k) clearance K022405 for MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC, Substantially Equivalent on 2002-08-12. 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: 2002-07-16
Decision date: 2002-08-12
Decision: Substantially Equivalent
Clearance type: Special
Location: New Brighton, MN, US

Download summary PDF View on FDA.gov ↗

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