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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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