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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 K191856
Device Name Compression Therapy Device
Applicant
Guangzhou Longest Science & Technology Co., Ltd.
5 & 6f, Bldg. B4, # 11, Kaiyuan Ave., Science City
Guangzhou,  CN 510530
Applicant Contact Xiaobing Luo
Correspondent
Guangzhou Keda Biological Tech Co., Ltd.
6f, #1 Tiantai Rd., Science City, Luogang District
Gaungzhou,  CN
Correspondent Contact Jet Li
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/11/2019
Decision Date 03/19/2020
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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