FDA.reportPublic FDA data

510(k) K210448

Device
Adhesive Electrode
Applicant
Shaoxing Yingtuo Healthcare Co.,Ltd.
510(k) number
K210448
Product code
GXY  
Decision
Substantially Equivalent (SESE)
Decision date
2021-08-31
Date received
2021-02-16
Regulation
882.1320
Classification name
Electrode, Cutaneous
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Haze XU
Address
#176 Shungeng Rd.,Baiguan St.,Shangyu Area, Shaoxing City,Zhejiang Shaoxing CN 312300 312300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K262664Rongjian Self-adhesive ElectrodeBozhou Rongjian Medical Appliance Co., Ltd.2026-10-20
K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd2026-08-27
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/S2026-07-14
K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.2026-06-26
K261522BioWave BioWrapsBiowave Corporation2026-06-03
K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi2026-05-08
K254183MR Conditional Cup ElectrodesTechnomed Europe2026-05-07
K252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.2026-05-01
K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)Otto Bock Healthcare Products GmbH2026-04-22
K260363Ceribell Brain Monitor HeadbandCeribell, Inc.2026-04-03
K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl2026-03-12
K254033Ceribell Instant EEG HeadsetCeribell, Inc.2026-02-09
K251381Ceribell Instant EEG Headcap (Small: C251, Medium: C252)Ceribell, Inc.2025-10-31
K250841Electrotherapy ElectrodesBaisheng Medical Co., Ltd.2025-08-13
K243788IceCap product lineBioserenity Medical Devices Group2025-03-13

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases