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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 K150043
Device Name Transcutaneous Electrical Nerve Stimulators (TENS)
Applicant
Andon Health Co, Ltd.
No 3, Jin Ping St.
Nankai District
Tianjin,  CN
Applicant Contact Liu Yi
Correspondent
Andon Health Co, Ltd.
No 3, Jin Ping St.
Nankai District
Tianjin,  CN
Correspondent Contact Liu Yi
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received01/09/2015
Decision Date 08/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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