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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, for muscle conditioning
510(k) Number K121719
Device Name SM TENS & PMS
Applicant
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
ROOM 1706, NO. 128 SONGLE RD
SONGJIANG AREA
SHANGHAI,  CN 201600
Applicant Contact DORIS DONG
Correspondent
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
ROOM 1706, NO. 128 SONGLE RD
SONGJIANG AREA
SHANGHAI,  CN 201600
Correspondent Contact DORIS DONG
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received06/11/2012
Decision Date 05/10/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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