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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 K191441
Device Name Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0)
Applicant
Maxstar Industrial Co., Ltd.
152 - 12 Hwanggeum-Ro 23beon-Gil, Yangchon-Eup
Gimpo,  KR 415843
Applicant Contact Jonghwa Lim
Correspondent
Med.Com
1809 Holland Dr.
Somerset,  NJ  08873
Correspondent Contact Chris Park
Regulation Number890.5650
Classification Product Code
IRP  
Date Received05/30/2019
Decision Date 03/05/2021
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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