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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 K964434
Device Name SD-970EMS ELECTRICAL MUSCULAR STIMULATOR
Applicant
Skylark Device Co., Ltd.
34 Chung Shan N. Rd.,
12th Floor , Sec. 3
Taipei,  TW
Applicant Contact GEORGE K.C. CHEN
Correspondent
Skylark Device Co., Ltd.
34 Chung Shan N. Rd.,
12th Floor , Sec. 3
Taipei,  TW
Correspondent Contact GEORGE K.C. CHEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/05/1996
Decision Date 10/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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