Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017619536

FEI Number

3017619536

Entity Name

SHENZHEN CHANGKE CONNECT ELECTRONICS CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

A1-2nd and A2-4th Floor of Factory Building, No.87 of Hengping Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen Guangdong 518115, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Changke Connect Electronics Co., Ltd. (Owner Number: 10078314)

Owner / Operator Contact Address

A1-2nd and A2-4th Floor of Factory Building, No.87 of Hengping Road, Baoan Community, Yuanshan Street, Longgang District, Shenzhen, CN-GD 518115, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K191428

PMA Number

N/A

All Registered Proprietary Names

Disposable EEG electrode (P01-001-00566; EEG electrode, Disp, 48IN, set of 10) Disposable EEG electrode (P01-001-00576; EEG electrode, Disp, 96IN, 20 sets of 14) Disposable EEG electrode (P01-001-00577; EEG electrode, Disp 120IN, 20 sets of 14) Disposable EEG electrode (P01-001-00567; EEG electrode, Disp, 72IN, set of 14) Disposable EEG electrode (P01-001-00574; EEG electrode, Disp, 48IN, 20 sets of 10) Disposable EEG electrode (P01-001-00569; EEG electrode, Disp, 120IN, set of 14) Disposable EEG electrode (P01-001-00568; EEG electrode, Disp, 96IN, set of 14) Disposable EEG electrode (P01-001-00575; EEG electrode, Disp, 72IN, 20 sets of 14) Disposable NIBP Cuff (model: CK-XT-88062-001, CK-XT-88062-003, CK-XT-88062-007, CK-XT-88062-008, CK-XT-88062-010) Disposable NIBP Cuff (model: CK-XT-88062-005) Generic Snap Connector Cable (model: P01-001-00578, P01-001-00564, P01-001-00562, P01-001-00563) Cable,Snap Connector,Disposable,96IN, 2.44m (Model: P01-001-00571) Cable,Snap Connector,Disposable,120IN, 35m (Model: P01-001-00572) Cable,Snap Connector,Disposable,72IN, 1.83m (Model: P01-001-00570) Disposable ECG Cable (model: CK-SMD-12C4-03A6) ECG Cable (model: P01-001-00565) ECG Lead, Disposable, 72IN, 1.83m (Model: P01-001-00573) Reusable NIBP Cuff (model: CK-XT-78211-001, CK-XT-78211-003, CK-XT-78211-005, CK-XT-78211-006, CK-XT-78211-007) Reusable NIBP Cuff (model: CK-XT-78211-008, CK-XT-78243-000, CK-XT-78243-001, CK-XT-78243-003, CK-XT-78243-005) Reusable NIBP Cuff (model: GCF1200, GCF1202, GCF1203, GCF1204, GCF1205, CK-XT-78243-007, CK-XT-78243-008) Disposable Temperature Probe (model: CK-TP-882111-611D, CK-TP-882121-611D) ECG Cable (model: CK-SMD-481A1-12AR2, CK-SMD-582A1-03AR2, CK-SMD-A82A1-03AN2, CK-SMD-582A1-05AR2, CK-SMD-982A1-05AR2) ECG Cable (model: CK-SMD-980A1-05IR2, CK-SMD-980A1-05AR2) ECG Cable (model: CK-SMD-582A1-03AN2, CK-SMD-480A1-12AR2) ECG Cable (model: P01-001-00545)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2022-05-06
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2020-11-17
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2021-05-18
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2020-11-17
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2020-11-17
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-11-17
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2020-10-18

Official Correspondent

Shunliang Duan

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Shenzhen Changke Connect Electronics Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017619536. Last updated year: 2026. Please use registration number 3017619536 when referencing this establishment in official correspondence.