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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 K230024
Device Name HI-EMT MAGSHAPE
Applicant
Beijing Sano Laser S&T Development Co., Ltd
Room 7-201, No.1, Caida 3rd Street, Nancai Town, Shunyi
District
Bejing,  CN 010-57150601
Applicant Contact Hongbo Zhang
Correspondent
Microkn Medical Technology Service (Shanghai) Co.,Ltd.
Room 901, No. 889, Pinglu Road, Jing'an District
Shanghai (Shanghai Jing'an HUAFA Center)
Shanghai,  CN 200435
Correspondent Contact Heather Wang
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/04/2023
Decision Date 09/06/2023
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
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