ELECTROPULSE - LOW BACK PAIN

Stimulator, Nerve, Transcutaneous, Over-the-counter

PAIN RELIEF TECHNOLOGIES

The following data is part of a premarket notification filed by Pain Relief Technologies with the FDA for Electropulse - Low Back Pain.

Pre-market Notification Details

Device IDK062532
510k NumberK062532
Device Name:ELECTROPULSE - LOW BACK PAIN
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant PAIN RELIEF TECHNOLOGIES 15048 SW CAPSTONE CT. Beaverton,  OR  97007
ContactKendall Gorham
CorrespondentKendall Gorham
PAIN RELIEF TECHNOLOGIES 15048 SW CAPSTONE CT. Beaverton,  OR  97007
Product CodeNUH  
Subsequent Product CodeILY
Subsequent Product CodeIRO
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-28
Decision Date2007-02-09

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