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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
Predetermined Change
Control Plan Authorized		 No
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