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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 K211283
Device Name Compressible Limb and Circulation Therapy System, Model POWER-Q2300
Applicant
Wonjin Mulsan Co., Ltd.
89, Geomdan-ro, Seo-gu
Incheon,  KR 22653
Applicant Contact Ha Yong Jung
Correspondent
Wonjin Mulsan Co., Ltd.
89, Geomdan-ro, Seo-gu
Incheon,  KR 22653
Correspondent Contact Ha Yong Jung
Regulation Number890.5650
Classification Product Code
IRP  
Date Received04/27/2021
Decision Date 09/14/2021
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
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