Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007616088

FEI Number

3007616088

Entity Name

JIANGYIN SINBON ELECTRONICS CO LTD

City/State/Country

Jiangyin Jiangsu, CN

Establishment Address

288 Chengjiang Middle Road Economic and Development Zone, Jiangyin Jiangsu 214434, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JIANGYIN SINBON ELECTRONICS CO LTD (Owner Number: 10028154)

Owner / Operator Contact Address

288, Chengjiang Middle Road, Jiangyin, CN-JS 214434, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NOX Reusable Sensor cables for PM7100 and Reusable Sensor cable for 5100C Foot Pedal; Adapter Cable O.R. Cable and Extension Carescape CO2 - LoFlo POLARMAP EP Electrical Cable APSG1AS Sleep recording device NOX-QDCA1A - QDC Adapter Kit,NOX-RIPDP20, Nox Disposable RIP Belts Altrix Precision Temperature Management System Reusable Patient Temperature Output Cable a. 8001-064-120

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2015-12-03
QEM	Cerebral Oximeter	Cardiovascular	Class 2	870.2700	2019-02-19
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2019-02-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-04-22
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Unknown	Class 3	N/A	2026-02-11
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Unknown	Class 3	N/A	2026-02-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2020-02-17
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Cardiovascular	Class 2	870.1220	2023-09-19
KZM	Device, Muscle Monitoring	Physical Medicine	Class 2	890.1375	2021-11-30
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2021-11-30
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2012-05-29
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2017-04-10
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-04-10

Official Correspondent

Yang Yang

US Agent Details

Winnie Chen Email: winniechen@sinbon.com Phone: (931) 2208988

Related Public Records

Same Entity

JIANGYIN SINBON 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
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K201432	Masimo Corporation	Masimo O3 Regional Oximeter System	2020-08-29
K211561	Covidien, LLC	INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor)	2021-12-05
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0022-2018	St. Jude Medical, Inc.	3	Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018	St. Jude Medical, Inc.	3	Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013	Advanced Neuromodulation Systems Inc.	3	The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007616088. Last updated year: 2026. Please use registration number 3007616088 when referencing this establishment in official correspondence.