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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 K191862
Device Name Compression Therapy Device Model LGT-2200SP
Applicant
Guangzhou Longest Science & Technology Co., Ltd.
5&6f, Building B4, No.11, Kaiyuan Avenue, Science City
guangzhou,  CN 510530
Applicant Contact xiaobing luo
Correspondent
Guangzhou KEDA Biological Tech Co., Ltd.
6F, No.1 TianTai road, Science City, LuoGang District
guangzhou,  CN
Correspondent Contact jet li
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/11/2019
Decision Date 10/29/2019
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
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