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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K253932
Device Name FACEGYM Pro Device (HD-109)
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Huaide Community Fuyong Town
Shenzhen,  CN 518103
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Kaiyan Medical Equipment Co., Ltd.
Bldg.#3 And Bldg.#5, 40th Of Fuxin St.
Huaide Community Fuyong Town
Shenzhen,  CN 518103
Correspondent Contact Alain Dijkstra
Regulation Number882.5890
Classification Product Code
NFO  
Date Received12/09/2025
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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