TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804

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 Transcutaneous Electr. Nerve Stimul Myostim 804.

Pre-market Notification Details

Device IDK853718
510k NumberK853718
Device Name:TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
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 Received1985-09-05
Decision Date1985-12-04

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