Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005785090

FEI Number

3005785090

Entity Name

TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD.

City/State/Country

Jiangyan Jiangsu, CN

Establishment Address

NO.6 JINXIN GARDEN LUOTANG SUB-DISTRICT, Jiangyan Jiangsu 225500, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

TAIZHOU CITY K&W INTERNATIONAL TRADE CO.,LTD. (Owner Number: 10029678)

Owner / Operator Contact Address

NO.6 JINXIN GARDEN LUOTANG SUB-DISTRICT, Jiangyan, CN-JS 225500, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100439

PMA Number

N/A

All Registered Proprietary Names

LENSMETER Confirmation Test STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC Cross Cylinder Trial Clip Retinoscope Rack; Skiascopic Rack Occluder APPLANATION TONOMETER REFRACTOMETER, OPHTHALMIC Ophthalmic Chair Keratometer Maddox Lens SOURCE, CARRIER, FIBEROPTIC LIGHT TABLE, INSTRUMENT, POWERED, OPHTHALMIC Instrument Table MICROSCOPE, OPERATING, NON-ELECTRIC, OPHTHALMIC Ultrasonic Biometer Keratometer OPHTHALMIC & OPHTHALMOLOGY, TRIAL FRAME Hand-held Fundus Camera Digital Hand-held Slit Lamp SET, LENS, TRIAL, OPHTHALMIC Lens Clock; Radian Aparatus Ultrasonic A/B Scan Vision Chart Non-contact infrared thermometer PROJECTOR, OPHTHALMIC Ophthalmic Prism Bar Slit Lamp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLM	Instrument, Measuring, Lens, Ac-Powered	Ophthalmic	Class 1	886.1425	2012-03-22
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	Class 1	886.5844	2015-01-29
HMF	Stand, Instrument, Ac-Powered, Ophthalmic	Ophthalmic	Class 1	886.1860	2012-03-22
HOR	Simulatan (Including Crossed Cylinder)	Ophthalmic	Class 1	886.1840	2015-01-29
HPB	Clip, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1410	2015-01-29
HMH	Rack, Skiascopic	Ophthalmic	Class 1	886.1750	2015-01-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2015-01-29
HKY	Tonometer, Manual	Ophthalmic	Class 2	886.1930	2018-06-12
HKO	Refractometer, Ophthalmic	Ophthalmic	Class 1	886.1760	2012-03-22
HME	Chair, Ophthalmic, Ac-Powered	Ophthalmic	Class 1	886.1140	2015-01-29
HLQ	Keratoscope, Ac-Powered	Ophthalmic	Class 1	886.1350	2015-01-29
HKR	Lens, Maddox	Ophthalmic	Class 1	886.1400	2015-01-29
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2012-03-22
HRJ	Table, Instrument, Powered, Ophthalmic	Ophthalmic	Class 1	886.4855	2012-03-22
HRB	Microscope, Operating, Non-Electric, Ophthalmic	General, Plastic Surgery	Class 1	878.4700	2012-03-22
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-06-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-12
HLQ	Keratoscope, Ac-Powered	Ophthalmic	Class 1	886.1350	2015-01-29
HPA	Frame, Trial, Ophthalmic	Ophthalmic	Class 1	886.1415	2015-01-14
PJZ	Camera, Ophthalmic, General-Use	Ophthalmic	Class 2	886.1120	2018-02-03
PUE	Biomicroscope, Slit-Lamp, Ac-Powered, Exempt	Ophthalmic	Class 2	886.1850	2018-02-03
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	Class 1	886.1405	2012-03-22
HLN	Gauge, Lens, Ophthalmic	Ophthalmic	Class 1	886.1420	2015-01-29
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-06-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-06-12
HOX	Chart, Visual Acuity	Ophthalmic	Class 1	886.1150	2015-01-27
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-24
HOS	Projector, Ophthalmic	Ophthalmic	Class 1	886.1680	2012-03-22
HKW	Prism, Bar, Ophthalmic	Ophthalmic	Class 1	886.1650	2015-01-29
HJO	Biomicroscope, Slit-Lamp, Ac-Powered	Ophthalmic	Class 2	886.1850	2015-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

TAIZHOU CITY K&W INTERNATIONAL TRADE 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
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0009-2022	DJO, LLC	2	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD, 2791/ INTELECT LEGEND XT COMBO US STD W/CART, 2782-10/ INTELECT TRANSPORT US STD, 2782-2/ INTELECT TRANSPORT US STD, 2843/ INTELECT VET 4CH COMBO PKG, 2845K/ KIT INTELECT VET 4CH COMBO PKG, 2863/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 5CM, 2863-10/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 10CM APPL, 2863-2/ SENIOR SOLUTIONS 2CH COMBO PKG US STD 2CM APPL, 2864/ SENIOR SOLUTIONS 4CH COMBO PKG US STD, 2761/ VECTRA GENISYS 2CH COMBO PKG US STD 5CM APPL, 2792/ VECTRA GENISYS 2CH COMBO US STD W/CART, 2761-10/ VECTRA GENISYS 2CH COMBO PKG US STD 10CM APPL, 2761-2/ VECTRA GENISYS 2CH COMBO PKG US STD 2CM APPL, 2762CC/ INT ADV 2CH COLOR COMBO INT'L 5CM APPL, 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 10CM APPL, 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD 2CM APPL, 2788/ LEGEND XT 4CH COMBO PKG US STD 5CM APPL, 2795/ INTELECT XT 4CH COMBO US STD 5CM APPL W/CART, 2788-10/ LEGEND XT 4CH COMBO PKG US STD 10CM APPL, 2795-10/ INTELECT XT4CH COMBO US STD 10CM APPL, 2788-2/ LEGEND XT 4CH COMBO PKG US STD 2CM APPL, 2795-2/ INTELECT XT 4CH COMBO US STD 2CM APPL, 2789/ VECTRA GENISYS 4CH COMBO PKG US 5CM APPL, 2796/ VECTRA GENISYS 4CH COMBO US STD W/CART, 2796K/ KIT VECTRA GENISYS 4CH COMBO P, 2789-10/ VECTRA GENISYS 4CH COMBO PKG US STD 10CM APPL, 2796-10/ VECTRA GENISYS 4CH COMBO US US STD 10CM APPL, 2789-2/ VECTRA GENISYS 4CH COMBO PKG US STD 2CM APPL, 2796-2/ VECTRA GENISYS 4CH COMBO US STD 2CM APPL, 2738/ INTELECT TRANSPORT COMBO PKG US STD, 8250KP/ KIT TRITON DTS PROMO, 6001/ INTELECT NEO, 2738-10/ INTELECT TRANSPORT COMBO PKG US STD, 2738-2/ INTELECT TRANSPORT COMBO PKG US STD, 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD, 2776/ INTELECT MOBILE INT'L STD 5CM APPL, 27800/ ULTRASOUND ON CART, 2776-BR/ INTELECT MOBILE INTL STD 5CM APPL BRAZIL, 2776-10/ INT MOBIL INT'L STD 10CM APPL, 2776-2/ INT MOBILE INT'L STD 2CM APPL, 2778/ INTELECT MOBILE COMBO INT'L STD 5CM APPL, 2778-10/ INTELECT MOBILE COMBO INT'L STD 10CM APPL, 2778-2/ INTELECT MOBILE COMBO INT'L STD 2CM APPL, 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD, 2756/ INTELECT VET 2CH COMBO PKG INT'L STD, 2844K/ KIT INTELECT VET 2CH COMBO PKG, 2782/ INTELECT TRANSPORT US STD, 2895K/ KIT CART ADAPT BL W/CT/SPEC US, 2872/ VECTRA GEN 2C COMBO W/O EMG PK US STD, 2876/ VECTR GEN 2C COMBO W/O EMG US STD W/CART, 2874/ VECTRA GEN 4C COMBO W/O EMG PK US STD, 2878/ VECTR GEN 4C COMBO W/O EM US STD W/CART, 7550/ INT LEGEND COMBO 4C US STD, INT001/ INTELECT LEGEND ULTRASOUND US STD, INTC B/ INT CB PKGD US STD, 39-0701/ DIRECT SUPPLY PANACEA VECTRA 2-CHNL ULTRASOUND/ESTIM COMBO, 39-0702/ DIRECT SUPPLY PANACEA VECTRA 4-CHNL ULTRASOUND/ESTIM COMBO, 13-4248/ GEL CONDUCTOR 24-8.5OZ BOTTLES, 15-1200/ INTELECT MOBILE 2 ULTRASOUND INTL SET EU PLUG, 15-1201/ INTELECT MOBILE 2 ULTRASOUND INTL SET ALL PLUGS, 15-1204/ INTELECT MOBILE 2 COMBO INTL SET EU PLUG, 15-1205/ INTELECT MOBILE 2 COMBO INTL SET ALL PLUGS, 2173KIT/ INTELECT RPW 2 120V INTERNATIONAL KIT US PLUG, 2174KIT/ INTELECT RPW 2 230V KIT EU PLUG, 2175KIT/ INTELECT RPW 2 100V KIT JPN PLUG, 2176KIT/ INTELECT RPW 2 120V USA KIT, 12-2756-1/ INTELECT VET 2CH COMBO PKG INTL STD, 2756K/ KIT INTELECT VET 2CH COMBO PKGUS STD, 70002/ NEO MODULE ULTRASOUND

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005785090. Last updated year: 2026. Please use registration number 3005785090 when referencing this establishment in official correspondence.