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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
510(k) Number K871647
Device Name STIMULATOR, ULTRASOUND AND MUSCLE
Applicant
Amy West
419 Main St.
Worcester,  MA  01608
Applicant Contact DONALD KUPPERSTEIN
Correspondent
Amy West
419 Main St.
Worcester,  MA  01608
Correspondent Contact DONALD KUPPERSTEIN
Regulation Number890.5860
Classification Product Code
IMG  
Date Received04/28/1987
Decision Date 06/29/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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