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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K250244
Device Name Compression Therapy Device (LGT-2210DS)
Applicant
Guangzhou Longest Medical Technology Co., Ltd.
301 Of Bldg. 1, #96, Chuangqiang Rd., Ningxi St.
Zengcheng District
Guanzhou,  CN 511399
Applicant Contact Xiaobing Luo
Correspondent
Guangzhou Keada Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Guangzhou,  CN 510010
Correspondent Contact Jett Li
Regulation Number890.5650
Classification Product Code
IRP  
Date Received01/27/2025
Decision Date 07/25/2025
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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