FDA 510(k)

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)

N.º K: K172887 · 2018-04-19

SolicitanteGuangzhou Xinbo Electronic Co., Ltd.

Fecha de decisión2018-04-19

Código de productoGXY

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172887. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)?

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K172887.

When did XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) receive FDA 510(k) clearance?

XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172887.

Who is the listed applicant for XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)?

The FDA 510(k) record lists Guangzhou Xinbo Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)?

The FDA product code for XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) is GXY.

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

Otros registros que enlistan a Guangzhou Xinbo Electronic Co., Ltd. como solicitante

K230711Pain Therapy Device(Model: P.T.S-X)K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)K231164Conductive carbon film electrode K231167Conductive Silicone Rubber Electrode K202671DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II)K212948Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)

Ver todos los 12 dispositivos →

Dispositivos relacionados (Código: GXY)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Copa MRI/CT (Modelos 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Copa MRI/CT-set (Modelos 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Copa MRI/CT-mini set (Modelos 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K254183MR Conditional Cup ElectrodesTechnomed Europe

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.