510(k) Report

FDA applicant

Viatherm Therapeutics, LLC

Annapolis, MD2 decisions2018–20250 recalls

FDA records 2 decisions for Viatherm Therapeutics, LLC (Annapolis, MD) from 2018 to 2025: 2 510(k) clearances. All are in product code IMJ (Diathermy, Shortwave, For Use In Applying…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, physical medicine panel, where it files most

How often FDA has decided Viatherm Therapeutics, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2018: 12025: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Viatherm Therapeutics, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat2decisions

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K173300ViaTherm BOOSTViatherm Therapeutics, LLC · 20182cite it

What has FDA decided for it lately?

  • K250376ViVYViatherm Therapeutics, LLC · 2025
  • K173300ViaTherm BOOSTViatherm Therapeutics, LLC · 2018

All 2 as Viatherm Therapeutics, LLC →