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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K152374
Device Name LL TENS 160A, LL TENS 160B
Applicant
Fuji Dynamics Ltd
1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road
Hong Kong,  CN
Applicant Contact Man Man Chung
Correspondent
Fuji Dynamics Ltd
1-3, 23/F., Laws Commercial Plaza, 788 Cheung Sha Wan Road
Hong Kong,  CN
Correspondent Contact Man Man Chung
Regulation Number882.5890
Classification Product Code
NUH  
Date Received08/21/2015
Decision Date 01/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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