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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
510(k) Number K231440
Device Name Combo Electrotherapy Device
Applicant
Shenzhen Roundwhale Technology Co. , Ltd.
202,2/F,Bldg. 27, Dafa Industrial Park, Longxi Community,
Longgang St., Longgang District
Shenzhen,  CN 518108
Applicant Contact Zeng Chunming
Correspondent
Shenzhen Roundwhale Technology Co. , Ltd.
202,2/F,Bldg. 27, Dafa Industrial Park, Longxi Community,
Longgang St., Longgang District
Shenzhen,  CN 518108
Correspondent Contact Amos Zou
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received05/18/2023
Decision Date 11/03/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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