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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 K200558
Device Name Smart Neck Stimulator
Applicant
GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD
No.1, 7/F, Yingfeng Business Center, No.8 Yixing Road,
Beijiao Town
Shunde District, Foshan City,  CN 528303
Applicant Contact Mao Hui Zhang
Correspondent
GUANDONG SKG INTELLIGENT TECHNOLOGY CO., LTD
No.1, 7/F, Yingfeng Business Center, No.8 Yixing Road,
Beijiao Town
Shunde District, Foshan City,  CN 528303
Correspondent Contact Fanny Yuan
Regulation Number882.5890
Classification Product Code
NUH  
Date Received03/03/2020
Decision Date 10/04/2021
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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