TS-700P CONTROL XP ELECTRICAL STIMULATOR

Stimulator, Electrical, Non-implantable, For Incontinence

MYO/KINETIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Myo/kinetic Systems, Inc. with the FDA for Ts-700p Control Xp Electrical Stimulator.

Pre-market Notification Details

Device IDK945292
510k NumberK945292
Device Name:TS-700P CONTROL XP ELECTRICAL STIMULATOR
ClassificationStimulator, Electrical, Non-implantable, For Incontinence
Applicant MYO/KINETIC SYSTEMS, INC. N. 84 W. 13562 LEON RD. Menomonee Falls,  WI  53051
ContactGregory L Johnson
CorrespondentGregory L Johnson
MYO/KINETIC SYSTEMS, INC. N. 84 W. 13562 LEON RD. Menomonee Falls,  WI  53051
Product CodeKPI  
CFR Regulation Number876.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-10-31
Decision Date1995-04-12

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