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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 K230829
Device Name TENS7000 Rechargeable (Model:TENS7000 Rechargeable)
Applicant
Chongqing Rob Linka Science and Technology Co., Ltd.
B3-2, Liangjiang Health Science And Technology City,
# 2 Yuekang Rd., Fuxing St., Beibei D
Chongqing,  CN 400700
Applicant Contact Yixuan Li
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.5890
Classification Product Code
NUH  
Date Received03/27/2023
Decision Date 04/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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