Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Metallic Fabric Electrodes

K-Number: K202636 · 2021-08-16

ApplicantGuangzhou Xinbo Electronic Co., Ltd.
Decision Date2021-08-16
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Metallic Fabric Electrodes 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 2021-08-16 under 510(k) number K202636. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Metallic Fabric Electrodes?

Metallic Fabric Electrodes is a medical device that received FDA 510(k) clearance on 2021-08-16. The listed applicant is Guangzhou Xinbo Electronic Co., Ltd.. The 510(k) number is K202636.

When did Metallic Fabric Electrodes receive FDA 510(k) clearance?

Metallic Fabric Electrodes received FDA 510(k) clearance on 2021-08-16, under 510(k) number K202636.

Who is the listed applicant for Metallic Fabric Electrodes?

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 Metallic Fabric Electrodes?

The FDA product code for Metallic Fabric Electrodes is GXY.

Other records listing Guangzhou Xinbo Electronic Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230711Pain Therapy Device(Model: P.T.S-X)K231789Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)K231167Conductive Silicone Rubber ElectrodeK231164Conductive carbon film electrodeK202671DR-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)

View all 12 devices →

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK254183MR Conditional Cup ElectrodesTechnomed EuropeK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.

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.

↑