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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lamp, Infrared, Therapeutic Heating
510(k) Number K101716
Device Name HVR PAIN RELIEF DEVICE
Applicant
H.V.R., Inc.
7821 Orion Ave.
Suite 200
Van Nuys,  CA  91406
Applicant Contact JESSANY GARRETT
Correspondent
H.V.R., Inc.
7821 Orion Ave.
Suite 200
Van Nuys,  CA  91406
Correspondent Contact JESSANY GARRETT
Regulation Number890.5500
Classification Product Code
ILY  
Date Received06/18/2010
Decision Date 01/11/2011
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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