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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 K202044
Device Name Powerpress Recovery Unit
Applicant
Hanuri Distribution, Inc.
9601 Owensmouth Ave. # 8
Chatsworth,  CA  91311
Applicant Contact Jung Hyun Moon
Correspondent
Hanuri Distribution, Inc.
9601 Owensmouth Ave. # 8
Chatsworth,  CA  91311
Correspondent Contact Jung Hyun Moon
Regulation Number890.5650
Classification Product Code
IRP  
Date Received07/23/2020
Decision Date 10/21/2020
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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