MANTRA TENS MODEL NT3

Stimulator, Nerve, Transcutaneous, For Pain Relief

MANTRA INTL. (HK) LTD.

The following data is part of a premarket notification filed by Mantra Intl. (hk) Ltd. with the FDA for Mantra Tens Model Nt3.

Pre-market Notification Details

Device IDK041520
510k NumberK041520
Device Name:MANTRA TENS MODEL NT3
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MANTRA INTL. (HK) LTD. 10235 GLADE AVE. Chatsworth,  CA  91311
ContactRobert B Spertell
CorrespondentRobert B Spertell
MANTRA INTL. (HK) LTD. 10235 GLADE AVE. Chatsworth,  CA  91311
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-07
Decision Date2004-09-03
Summary:summary

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