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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K240108
Device Name Wrap Accessory Electrodes (GMX-ABSBELT01; GMX-ABSBELT02; GMX-WRIST01; GMX-ELBOW01; GMX-LEG01, GMX-ANKLE01, GMX-KNEE01; GMX-FOOT PAD01; GMX-GLOVES01; SHOULDER01; GMX-NCK01)
Applicant
Gymmax Technology Shenzhen Co., Ltd.
5f 4th Bldg., Heping Complex(4th Bldg. Huimingsheng
Technology Park)Fuhai Subdistrict, Baoan District
Shenzhen,  CN 518103
Applicant Contact Benson Wang
Correspondent
Imd Medical & Drug Technology Service Institutions
Rm. 308, Bldg. 11, # 23 Jinqu Rd., Wanjiang District
Dongguan,  CN 523039
Correspondent Contact Salon Chen
Regulation Number882.1320
Classification Product Code
GXY  
Date Received01/16/2024
Decision Date 06/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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