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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 K912642
Device Name EMS300, EMS400, EMS8000
Applicant
Skylark Device Co., Ltd.
12 Floor 34, Sec. 3 Chung Shan
N. Rd.
Taipei, Taiwan, R.O.C.,  TW
Applicant Contact CHEN
Correspondent
Skylark Device Co., Ltd.
12 Floor 34, Sec. 3 Chung Shan
N. Rd.
Taipei, Taiwan, R.O.C.,  TW
Correspondent Contact CHEN
Regulation Number890.5850
Classification Product Code
IPF  
Date Received06/14/1991
Decision Date 12/09/1991
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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