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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 K253790
Device Name High Intensity Focused Electromagnetic Stimulation Device (FE60)
Applicant
Beijing Winkonlaser Technology Limited
Rm. 407, 4th Floor, Bldg. 9#, Yard 3#, Boda Rd.
Chaoyang District
Beijing,  CN 100020
Applicant Contact Sindy Chang
Correspondent
Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Bldg. #15, Xiyuehui, #5
Yihe N. Rd., Fangshan District
Beijing,  CN 102401
Correspondent Contact Ray Wang
Regulation Number890.5850
Classification Product Code
NGX  
Date Received11/28/2025
Decision Date 08/13/2026
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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