NEURO WAVE 6

Stimulator, Nerve, Transcutaneous, For Pain Relief

LHASA OMS, INC.

The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Neuro Wave 6.

Pre-market Notification Details

Device IDK062003
510k NumberK062003
Device Name:NEURO WAVE 6
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth,  MA  02189
ContactMark W Sheehan
CorrespondentMark W Sheehan
LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth,  MA  02189
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-17
Decision Date2007-09-19
Summary:summary

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