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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 K240292
Device Name Transcutaneous Electrical Nerve Stimulator (9029SCM)
Applicant
Hong Kong Etech Groups Limited
Rm.747,7/F Star Hse 3 Salisbury Rd. Tst
Hong Kong,  CN 999077
Applicant Contact Haixin Chen
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Riley Chen
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received02/01/2024
Decision Date 03/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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