FDA 510(k)

ViVY

N.º K: K250376 · 2025-11-05

Fecha de decisión2025-11-05

Código de productoIMJ

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

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

Preguntas frecuentes

What is the ViVY?

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

When did ViVY receive FDA 510(k) clearance?

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

Who is the listed applicant for ViVY?

The FDA 510(k) record lists Viatherm Therapeutics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViVY?

The FDA product code for ViVY is IMJ.

Otros registros que enlistan a Viatherm Therapeutics, LLC como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K173300ViaTherm BOOST

Dispositivos relacionados (Código: IMJ)

K252963BTL-899TTBTL Industries, Inc.K243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC K162240ProMedTek Model C1400 Shortwave Diathermy DevicePromedtek, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.