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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)
Chongqing Rob Linka Science And Technology Co., Ltd.
B3-2, Liangjiang Health Science And Technology City,
No. 2 Yuekang Road, Fuxing Street, Beibei D
Chongqing,  CN 400700
Applicant Contact Yixuan Li
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.5890
Classification Product Code
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