Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

OW100S (model OW100S-US)

N.º K: K213120 · 2022-10-12

SolicitanteTissue Regeneration Technologies, LLC Dba AS Softwave Trt
Fecha de decisión2022-10-12
Código de productoISA
Comité asesorPM
DecisiónSubstantially Equivalent

Resumen del dispositivo

OW100S (model OW100S-US) is the device name listed in this FDA 510(k) record. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K213120. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the OW100S (model OW100S-US)?

OW100S (model OW100S-US) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. The 510(k) number is K213120.

When did OW100S (model OW100S-US) receive FDA 510(k) clearance?

OW100S (model OW100S-US) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K213120.

Who is the listed applicant for OW100S (model OW100S-US)?

The FDA 510(k) record lists Tissue Regeneration Technologies, LLC Dba AS Softwave Trt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OW100S (model OW100S-US)?

The FDA product code for OW100S (model OW100S-US) is ISA.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: ISA)

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.

K243488VMAT PROTermosaludK240358ShockPhysio Mobile (model SW3200 Basic)Shenzhen Dongdixin Technology Co., Ltd.K221865BTL-094BTL Industries, Inc.K210166Omnispec ED1000Medispec, Ltd.K220538DolorClast RadialE.M.S Electro Medical Systems S.AK210451OrthoGold 100Tissue Regeneration Technologies, LLC

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.

↑