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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(k) Number K853718
Device Name TRANSCUTANEOUS ELECTR. NERVE STIMUL MYOSTIM 804
Applicant
ELECTRO THERAPEUTIC DEVICES, INC.
570 HOOD RD., STE. 14
MARKHAM, ONTARIO,  CA L3R 4G7
Applicant Contact CHOONG
Correspondent
ELECTRO THERAPEUTIC DEVICES, INC.
570 HOOD RD., STE. 14
MARKHAM, ONTARIO,  CA L3R 4G7
Correspondent Contact CHOONG
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/05/1985
Decision Date 12/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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