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Xuzhou Yongkang Electronic Science Technology Co., Ltd: FDA-registered device maker in Xuzhou Jiangsu, China, 5 510(k) clearances

Name: Xuzhou Yongkang Electronic Science Technology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Xuzhou Yongkang Electronic Science Technology Co., Ltd is registered with the FDA (registration 3017406171) in Xuzhou Jiangsu, China. It lists 10 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 6, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3017406171
Address: 2nd&3rd floor of Building No.5, Block B, Huaihai Biomedical Industry Park, No. 5 Tengzhai North Road, Xuzhou High-tech Industrial Development Zone, Xuzhou Jiangsu, China, 221000
Owner or operator: Xuzhou Yongkang Electronic Science Technology Co., Ltd (10054941)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 16, 2017
Registered through: 2027
Brand names listed: Arm Blood Pressure Monitor-YK-BPA1, Arm Blood Pressure Monitor-YK-BPA2, Arm Blood Pressure Monitor-YK-BPA3, Arm Blood Pressure Monitor-YK-BPA4, Arm Type Blood Pressure Monitor YK-IBPA1,YK-IBPA2,YK-IBPA3,YK-IBPA4,YK-IBPA5, BPX800US-Fingertip Pulse Oximeter, BPX801US-Fingertip Pulse Oximeter, Braun Pulse Oximeter :BPX801US and more

Devices it lists

Device	Product code	Class	Role	Source
Continuous Measurement Thermometer	FLL	2	Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Repackager or relabeler	accessdata.fda.gov
Light, Ultraviolet, Dermatological	FTC	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Repackager or relabeler	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Manufacturer	accessdata.fda.gov
Pump, Nebulizer, Electrically Powered	JPW	1	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Manufacturer	accessdata.fda.gov
Unit, Oral Irrigation	EFS	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 6, 2020	K191571	UV Radiation Treatment System	FTC	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	accessdata.fda.gov
March 24, 2019	K183491	Arm Blood Pressure Monitor	DXN	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	accessdata.fda.gov
July 11, 2018	K180314	Infrared Thermometer	FLL	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	accessdata.fda.gov
March 9, 2018	K162616	Wrist Type Blood Pressure Monitor	DXN	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	accessdata.fda.gov
May 8, 2017	K161938	Fingertip Pulse Oximeter	DQA	Substantially Equivalent	Xuzhou Yongkang Electronic Science Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated February 6, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.