FDA 510(k)

Therapy US

N.º K: K252273 · 2025-12-12

SolicitanteDmc Importação E Exportação DE Equipamentos Ltda

Fecha de decisión2025-12-12

Código de productoNHN

Comité asesorPM

DecisiónSubstantially Equivalent

Resumen del dispositivo

Therapy US is the device name listed in this FDA 510(k) record. The listed applicant is Dmc Importação E Exportação DE Equipamentos Ltda. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K252273. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Therapy US?

Therapy US is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Dmc Importação E Exportação DE Equipamentos Ltda. The 510(k) number is K252273.

When did Therapy US receive FDA 510(k) clearance?

Therapy US received FDA 510(k) clearance on 2025-12-12, under 510(k) number K252273.

Who is the listed applicant for Therapy US?

The FDA 510(k) record lists Dmc Importação E Exportação DE Equipamentos Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Therapy US?

The FDA product code for Therapy US is NHN.

Ensayos clínicos relacionados

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: NHN)

K254024MR5 Activ ProMulti Radiance Medical, Inc.K251903Erchonia DPN Laser (Model# EVRL)Erchonia Corporation K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd..K232813Therapy EC, Therapy XTDmc Importacao E Exportacao DE Equipamentos Ltda K231409Erchonia FX-405Erchonia Corporation K212189FibroLuxMulti Radiance Medical

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.