PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT

Stimulator, Nerve, Transcutaneous, For Pain Relief

REHABILICARE, INC.

The following data is part of a premarket notification filed by Rehabilicare, Inc. with the FDA for Promax-xp, Tens And Microcurrent Device; Promax-tens, Tens Device; Promax-libra, Tens Device; Promax-mc, Microcurrent.

Pre-market Notification Details

Device IDK011017
510k NumberK011017
Device Name:PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MC, MICROCURRENT
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton,  MN  55112
ContactEdward F Valdez
CorrespondentEdward F Valdez
REHABILICARE, INC. 1811 OLD HIGHWAY 8 New Brighton,  MN  55112
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-04
Decision Date2001-09-24

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