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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K250242
Device Name Compression Therapy Device (LGT-2202DVT)
Applicant
Guangzhou Longest Medical Technology Co., Ltd.
301 Of Bldg. 1, #96, Chuangqiang Rd., Ningxi St.
Zengcheng District
Guangzhou,  CN 510010
Applicant Contact Xiaobing Luo
Correspondent
Guangzhou Keada Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Guangzhou,  CN 510020
Correspondent Contact Jett Lee
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/27/2025
Decision Date 04/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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