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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 K212491
Device Name Air Relax Pro Model AR-4.0
Applicant
Diode Art Engineering doing business as Air Relax
9535 Brasher St
Pico Rivera,  CA  90660
Applicant Contact Beomjoon Lee
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/09/2021
Decision Date 09/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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