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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 K141861
Device Name HILTHERA 4.0
Applicant
Jeisys Medical, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Applicant Contact Priscilla Chung
Correspondent
Jeisys Medical, Inc.
2651 E. Chapman Ave., Suite 110
Fullerton,  CA  92831
Correspondent Contact Priscilla Chung
Regulation Number890.5500
Classification Product Code
ILY  
Date Received07/10/2014
Decision Date 01/07/2015
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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