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510(k) K173300

ViaTherm BOOST by Viatherm Therapeutics, LLC — Product Code IMJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2018
Date Received
October 17, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class
Class II
Regulation Number
890.5290
Review Panel
PM
Submission Type

Other clearances by Viatherm Therapeutics, LLC

  • K250376 — ViVY (November 5, 2025)

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  • K223620 — Reprieve by RegenesisTM (May 24, 2023)
  • K182363 — BTL-703 (January 24, 2019)
  • K162240 — ProMedTek Model C1400 Shortwave Diathermy Device (November 17, 2016)
  • K161862 — ThermoPro (November 14, 2016)
  • K153456 — Megapulse III Shortwave Diathermy (June 14, 2016)
  • K131926 — THERMOPULSE (July 24, 2014)
  • K131899 — SW-THERM (March 14, 2014)
  • K121123 — BIOFUSIONARY BEBE (March 10, 2014)