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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 K931715
Device Name PURECARE AT-903 T.E.N.S.
Applicant
Fuching Enterprise Co., Ltd.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact ALAN P SCHWARTZ
Correspondent
Fuching Enterprise Co., Ltd.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact ALAN P SCHWARTZ
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received04/06/1993
Decision Date 01/27/1994
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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