Cleared Traditional

ViaTherm BOOST

K173300 · Viatherm Therapeutics, LLC · Physical Medicine
May 2018
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K173300 is an FDA 510(k) clearance for the ViaTherm BOOST, a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II — Special Controls, product code IMJ), submitted by Viatherm Therapeutics, LLC (Annapolis, US). The FDA issued a Cleared decision on May 1, 2018, 196 days after receiving the submission on October 17, 2017. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number K173300 FDA.gov
FDA Decision Cleared SESE
Date Received October 17, 2017
Decision Date May 01, 2018
Days to Decision 196 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5290