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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 K231648
Device Name Muscle Stimulator
Shenzhen Yiran Intelligent Co., Ltd
Floor 6, No. 531 Nanpu Road, Huangpu Community,
Xinqiao Street, Bao'an District,
Shenzhen,  CN 518125
Applicant Contact Fengqing Chen
Huide Medical Technology Service (Shenzhen) Group Co., Ltd.
Room 703, Building 16, South Bank Plaza,
Exhibition Bay, Zhancheng Community, Fuhai Street,
Shenzhen,  CN 518053
Correspondent Contact Tulin Li
Regulation Number882.5890
Classification Product Code
Subsequent Product Code
Date Received06/05/2023
Decision Date 03/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No