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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 K843638
Device Name HEALTH PULSE FA-222 POWER MUSCLE STIMUL
Applicant
Therapeutic Equipment Corp.
60 Page Rd.
Clifton,  NJ  07012
Applicant Contact ALAN P SCHWARTZ
Correspondent
Therapeutic Equipment Corp.
60 Page Rd.
Clifton,  NJ  07012
Correspondent Contact ALAN P SCHWARTZ
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/17/1984
Decision Date 11/23/1984
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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