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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 K050921
Device Name EASYSTIM NMS-28
Applicant
Easy Med Instrument Co., Ltd.
2/F-3/F, #2 Beihai Da Rd.
Lunjiao, Shunde
Guangdong,  CN 528303
Applicant Contact JEFFERY WU
Correspondent
Easy Med Instrument Co., Ltd.
2/F-3/F, #2 Beihai Da Rd.
Lunjiao, Shunde
Guangdong,  CN 528303
Correspondent Contact JEFFERY WU
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
GZJ  
Date Received04/13/2005
Decision Date 12/12/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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