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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 K963729
Device Name SD-610M(ALSO KNOWN AS STANDARD TENS, SD-609M,SD-611M, GLC-I STANDARD)
Applicant
Skylark Device Co., Ltd.
34 Chung Shan N. Rd.,
12th Floor , Sec. 3
Taipei,  TW
Applicant Contact GEORGE CHEN
Correspondent
Skylark Device Co., Ltd.
34 Chung Shan N. Rd.,
12th Floor , Sec. 3
Taipei,  TW
Correspondent Contact GEORGE CHEN
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received09/16/1996
Decision Date 02/13/1997
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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