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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 K233040
Device Name EMS/TENS Massager Device
Applicant
Shenzhen IMDK Medical Technology Co., Ltd.
904, 9F, Guangming Tianan Cloud Park Building, 255
Zhenmei Road, Zhenmei Community,Xinhu Street
Shenzhen,  CN 518107
Applicant Contact Yuan Xia
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM. 1801, No. 161 East, Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received09/25/2023
Decision Date 02/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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