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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 K021754
Device Name APEX MEDICAL DIGITAL EMS TS1311, TS1312
Applicant
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Applicant Contact ALAN CHANG
Correspondent
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Correspondent Contact ALAN CHANG
Regulation Number890.5850
Classification Product Code
IPF  
Date Received05/29/2002
Decision Date 06/28/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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