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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K875317
Device Name ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID
Applicant
Electro Therapeutic Devices, Inc.
570 Hood Rd., Suite 14
Markham, Ontario,  CA L3R 4G7
Applicant Contact K. C CHOONG
Correspondent
Electro Therapeutic Devices, Inc.
570 Hood Rd., Suite 14
Markham, Ontario,  CA L3R 4G7
Correspondent Contact K. C CHOONG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received12/29/1987
Decision Date 09/08/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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