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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 K222867
Device Name AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)
Applicant
Andon Health Co, Ltd.
# 3 Jin Ping St.,Ya An Rd.
Nankai District
Tianjin,  CN 300190
Applicant Contact Liu Yi
Correspondent
Andon Health Co, Ltd.
# 3 Jin Ping St.,Ya An Rd.
Nankai District
Tianjin,  CN 300190
Correspondent Contact Liu Yi
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NYN  
Date Received09/22/2022
Decision Date 12/21/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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