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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 K861739
Device Name TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR
Applicant
J.A. Preston Corp.
60 Page Rd.
Clifton,  NJ  07012
Applicant Contact ALAN P SCHWARTZ
Correspondent
J.A. Preston Corp.
60 Page Rd.
Clifton,  NJ  07012
Correspondent Contact ALAN P SCHWARTZ
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/06/1986
Decision Date 06/09/1986
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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