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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
510(k) Number K173300
Device Name ViaTherm BOOST
Applicant
Viatherm Therapeutics, LLC
201 Defense Hwy.
Suite 260
Annapolis,  MD  21401
Applicant Contact Michael J. Thomas
Correspondent
Graematter, Inc.
1324 Clarkson Clayton Center #332
St.Louis,  MO  63011
Correspondent Contact Melissa Walker
Regulation Number890.5290
Classification Product Code
IMJ  
Date Received10/17/2017
Decision Date 05/01/2018
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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