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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 K223428
Device Name Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Applicant
Shenzhen Leqing Medical Instrument Co., Ltd
2-3/F, Building D, No.31 Fangkeng Road, Longgang
Shenzhen,  CN 518000
Applicant Contact Shaodong Wang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm2401, ZhenYe International Center, No.3101-90 Qianhai Road
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/14/2022
Decision Date 05/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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