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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 K220005
Device Name TENS & PMS Unit
Shenzhen Yuehua Xinsen Technology Co., Ltd.
No. 27-201, Zhongwu 3rd Road, Zhongwu Community,
Hangcheng Street, Bao’an District
Shenzhen,  CN 518128
Applicant Contact Evin Li
Guangdong Jianda Medical Technology Co., Ltd.
906 Room, Longxiang Garden, Tianhe district
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received01/04/2022
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No