ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)

Stimulator, Muscle, Powered

UNIVERSAL TECHNOLOGY SYSTEMS, INC.

The following data is part of a premarket notification filed by Universal Technology Systems, Inc. with the FDA for Electrical Muscle Stimulator Device ( Pgs-4000).

Pre-market Notification Details

Device IDK980346
510k NumberK980346
Device Name:ELECTRICAL MUSCLE STIMULATOR DEVICE ( PGS-4000)
ClassificationStimulator, Muscle, Powered
Applicant UNIVERSAL TECHNOLOGY SYSTEMS, INC. 5150-4 TIMUQUANA RD. Jacksonville,  FL  32210
ContactGary Heiney
CorrespondentGary Heiney
UNIVERSAL TECHNOLOGY SYSTEMS, INC. 5150-4 TIMUQUANA RD. Jacksonville,  FL  32210
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-28
Decision Date1998-04-28

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