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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K233492
Device Name EMS Neck Massager
Applicant
Xiamen Comfier Technology Co., Ltd
2/F,3/F,4/F,5/F, No.65 Sunban South Road, Jimei District
Xiamen,  CN 361012
Applicant Contact Petoula N/A
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Room 1407, Jingting Building, Dongzhou Community,
Guangming Street, Guangming District
Shenzhen,  CN 518107
Correspondent Contact Reanny Wang
Regulation Number890.5850
Classification Product Code
NGX  
Date Received10/30/2023
Decision Date 12/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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