WELLNESSPRO 2010

Stimulator, Nerve, Transcutaneous, For Pain Relief

INTELSOURCE GROUP, INC.

The following data is part of a premarket notification filed by Intelsource Group, Inc. with the FDA for Wellnesspro 2010.

Pre-market Notification Details

Device IDK062616
510k NumberK062616
Device Name:WELLNESSPRO 2010
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant INTELSOURCE GROUP, INC. 1676 VILLAGE GREEN SUITE A Crofton,  MD  21114
ContactE.j. Smith
CorrespondentE.j. Smith
INTELSOURCE GROUP, INC. 1676 VILLAGE GREEN SUITE A Crofton,  MD  21114
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-05
Decision Date2007-07-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861284002605 K062616 000
B243SSWP2010PLUS0 K062616 000

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