'MYOSTIM EX'

Stimulator, Nerve, Transcutaneous, For Pain Relief

ELECTRO THERAPEUTIC DEVICES, INC.

The following data is part of a premarket notification filed by Electro Therapeutic Devices, Inc. with the FDA for 'myostim Ex'.

Pre-market Notification Details

Device IDK863568
510k NumberK863568
Device Name:'MYOSTIM EX'
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario,  CA L3r 4g7
ContactChoong
CorrespondentChoong
ELECTRO THERAPEUTIC DEVICES, INC. 570 HOOD RD., STE. 14 Markham, Ontario,  CA L3r 4g7
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-12
Decision Date1986-10-24

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