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Tianjin Choice Medical Device Co., Ltd.: FDA-registered device maker in Tianjin, China, 10 510(k) clearances

Name: Tianjin Choice Medical Device Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Tianjin Choice Medical Device Co., Ltd. is registered with the FDA (registration 3015142815) in Tianjin, China. It lists 12 device types. The FDA files 10 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3015142815
Address: No. 6 Quanhe Road, Wuqing District Development Zone, Tianjin, China, 301700
Owner or operator: BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. (9106400)
Roles: Contract manufacturer, Exporter to the US, Foreign private label distributor, Repackager or relabeler
First device listed: August 27, 2008
Registered through: 2027
Brand names listed: Fingertip Pulse Oximeter HCSM70P, Fingertip Pulse Oximeter MD300C13, Fingertip Pulse Oximeter MD300C15F, Fingertip Pulse Oximeter MD300C1C, Fingertip Pulse Oximeter MD300C2, Fingertip Pulse Oximeter MD300C20, Fingertip Pulse Oximeter MD300C21C, Fingertip Pulse Oximeter MD300C26 and more

Devices it lists

Device	Product code	Class	Role	Source
Bottle, Collection, Vacuum	KDQ	2	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
Clinical Electronic Thermometer	SDV	2	Contract manufacturer	accessdata.fda.gov
Continuous Measurement Thermometer	FLL	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Electrocardiograph	DPS	2	Contract manufacturer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Exporter to the US, Repackager or relabeler	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Contract manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Oximeter, Infrared, Sporting, Aviation	OCH	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Oximeter, Wellness	PGJ	2	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Reminder, Medication	NXQ	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Contract manufacturer, Exporter to the US	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
December 16, 2025	K252268	V series portable oxygen concentrator (V5, V5C, V6, V6C)	CAW	Substantially Equivalent	Shenzhen Harveymed Technology Co., Ltd.	accessdata.fda.gov
February 11, 2022	K211400	Pulse Oximeter	DQA	Substantially Equivalent	Beijing Choice Electronic Technology Co., Ltd.	accessdata.fda.gov
January 21, 2022	K211752	Infrared Thermometer	FLL	Substantially Equivalent	Beijing Choice Electronic Technology Co., Ltd.	accessdata.fda.gov
November 21, 2016	K160508	Electronic Pulse Stimulator	NUH	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
April 18, 2016	K152563	Pulse Oximeter (MD300M/MD300K2)	DQA	Substantially Equivalent	Beijing Choice Electronic Technology Co., Ltd.	accessdata.fda.gov
October 16, 2013	K131047	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
October 3, 2013	K130947	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
May 10, 2013	K123871	FINGERTIP PULSE OXIMETER	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
December 2, 2010	K101577	MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov
March 4, 2009	K082487	M-50 SERIES SPO2 SENSOR	DQA	Substantially Equivalent	Beijing Choice Electronic Technololgy Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 16, 2025. 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.