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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 K252154
Device Name Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)
Applicant
Guangzhou Longest Medical Technology Co., Ltd.
301 Of Bldg. 1, # 96, Chuangqiang Rd., Ningxi St.,
Zengcheng District
Guangzhou,  CN 511399
Applicant Contact Xiaobing Luo
Correspondent
Guangdong Jianda Medical Technology Co., Ltd.
906 Rm., Longxiang Garden, Tianhe District
Guangzhou,  CN
Correspondent Contact Jett Li
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NYN  
Date Received07/09/2025
Decision Date 12/09/2025
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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