MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC

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 Modification To Promax-xp, Tens And Microcurrent Device; Promax-tens, Tens Device; Promax-libra, Tens Device; Promax-mic.

Pre-market Notification Details

Device IDK022405
510k NumberK022405
Device Name:MODIFICATION TO PROMAX-XP, TENS AND MICROCURRENT DEVICE; PROMAX-TENS, TENS DEVICE; PROMAX-LIBRA, TENS DEVICE; PROMAX-MIC
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-16
Decision Date2002-08-12
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.