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FDA 510(k)

ViVY

K-Number: K250376 · 2025-11-05

ApplicantViatherm Therapeutics, LLC
Decision Date2025-11-05
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ViVY is a medical device manufactured by Viatherm Therapeutics, LLC. It received FDA 510(k) clearance on 2025-11-05 under approval number K250376. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViVY?

ViVY is a medical device that received FDA 510(k) clearance on 2025-11-05. It is manufactured by Viatherm Therapeutics, LLC. The 510(k) number is K250376.

When was ViVY approved by the FDA?

ViVY received FDA 510(k) clearance on 2025-11-05, under approval number K250376.

What company makes ViVY?

ViVY is manufactured by Viatherm Therapeutics, LLC.

What is the FDA product code for ViVY?

The FDA product code for ViVY is IMJ.

Other Devices by Viatherm Therapeutics, LLC

K173300ViaTherm BOOST

Related Devices (Code: IMJ)

K162240ProMedTek Model C1400 Shortwave Diathermy DevicePromedtek, Inc. K161862ThermoProZimmer Medizinsysteme GmbH K153456Megapulse III Shortwave DiathermyAccelerated Care Plus K173300ViaTherm BOOSTViatherm Therapeutics, LLC K182363BTL-703BTL Industries, Inc. K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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