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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 K853885
Device Name MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA
Applicant
Uniking Intl. Corp.
2213 S. Vermont Ave.
Torrance,  CA  90502
Applicant Contact TOSHI CHEN
Correspondent
Uniking Intl. Corp.
2213 S. Vermont Ave.
Torrance,  CA  90502
Correspondent Contact TOSHI CHEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/19/1985
Decision Date 01/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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