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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 K002339
Device Name AEMS V, EMS-1000, MODEL TS-140500 AND AEMS VI, EMS-1000 PLUS, MODEL TS-140600
Applicant
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Applicant Contact DANIEL LEE
Correspondent
Apex Medical Corp.
10th Floor , # 31, Lane 169,
Kang Ning St.
Shi-Chih, Taipei Hsien,  TW
Correspondent Contact DANIEL LEE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received08/01/2000
Decision Date 08/24/2001
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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