MYOSTIM(TM), MODEL 6600

Stimulator, Muscle, Powered

MEDICAL DEVICES, INC.

The following data is part of a premarket notification filed by Medical Devices, Inc. with the FDA for Myostim(tm), Model 6600.

Pre-market Notification Details

Device IDK872753
510k NumberK872753
Device Name:MYOSTIM(TM), MODEL 6600
ClassificationStimulator, Muscle, Powered
Applicant MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul,  MN  55112
ContactBruce Macfarlane,phd
CorrespondentBruce Macfarlane,phd
MEDICAL DEVICES, INC. 833 THIRD ST. SOUTHWEST St. Paul,  MN  55112
Product CodeIPF  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-13
Decision Date1987-10-01

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