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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 K210240
Device Name Air Compression Therapy Device, model HW6007
Applicant
Konliking Tech & Dev. Limited
The 2nd Floor, Building D, No 168, Hengping Road, Longgang
Shenzhen,  CN 518115
Applicant Contact Jane Chen
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 1813#, Gebu commerical building, Hongxing community,
Songgang street
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received01/29/2021
Decision Date 02/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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