UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500

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 Uts Electrical Muscle Stimulation Device-pgs 1500.

Pre-market Notification Details

Device IDK905107
510k NumberK905107
Device Name:UTS ELECTRICAL MUSCLE STIMULATION DEVICE-PGS 1500
ClassificationStimulator, Muscle, Powered
Applicant UNIVERSAL TECHNOLOGY SYSTEMS, INC. P.O. BOX 7908 Jacksonville,  FL  32238
ContactThomas J Mcenany
CorrespondentThomas J Mcenany
UNIVERSAL TECHNOLOGY SYSTEMS, INC. P.O. BOX 7908 Jacksonville,  FL  32238
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-13
Decision Date1991-08-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.