Data / Medical devices / Oximeter, Infrared, Sporting, Aviation

Oximeter, Infrared, Sporting, Aviation (OCH): 40 FDA-registered makers in 5 countries

Name: FDA-registered makers of Oximeter, Infrared, Sporting, Aviation
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

40 establishments in 5 countries are registered with the FDA to make Oximeter, Infrared, Sporting, Aviation (product code OCH, Class 2, 21 CFR 870.2700). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this device Makers in China Watch this device

Product code: OCH
Device class: 2
Regulation: 870.2700
Medical specialty: Cardiovascular

Makers by country

Country	Makers
China	29
United States	5
Vietnam	3
Taiwan	2
Mexico	1

Makers of Oximeter, Infrared, Sporting, Aviation

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Source
Amarigo Inc	Los Angeles, CA, United States	Manufacturer	api.fda.gov
Andon Health Co., Ltd	Tianjin, China	Exporter to the US, Specification developer	api.fda.gov
Avita (wujiang) Co., Ltd	Wujiang City Jiangsu, China	Manufacturer	api.fda.gov
Avita Corporation	San-Chung District, New Taipei City, Taiwan	Manufacturer	api.fda.gov
Andon Medical co., LTD	Tianjin, China	Contract manufacturer	api.fda.gov
Beijing Choice Electronic Technololgy Co., Ltd.	Beijing, China	Exporter to the US, Manufacturer	api.fda.gov
Changsha Brilliant Easesyn Technology Co.,ltd.	Xiangjiang New Area, Changsha, Hunan Province,, China	Manufacturer	api.fda.gov
Contec Medical Systems Co., Ltd	Qinhuangdao Hebei, China	Manufacturer	api.fda.gov
Giantsun Power Electronics (vietnam) Co., Ltd	Hanoi Ha Noi, Vietnam	Contract manufacturer	api.fda.gov
Golden Smart Home Technology Corp.	Hsinchu City Hsinchu(City), Taiwan	Manufacturer	api.fda.gov
Guangdong Biolight Meditech Co., Ltd	Zhuhai Guangdong, China	Manufacturer	api.fda.gov
Guangdong Health Tree Medical Technology Co., Ltd.	Zhuhai Guangdong, China	Manufacturer	api.fda.gov
Hunan Accurate Bio-Medical Technology Co., Ltd.	Changsha Hunan, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.	Mexicali Mexico, Mexico	Manufacturer	api.fda.gov
Jiangsu Konsung Bio-Medical Science And Technology Co Ltd	Danyang Jiangsu, China	Manufacturer	api.fda.gov
Jiangxi Aicare Medical Technology Co., Ltd	Fuzhou Jiangxi, China	Exporter to the US, Manufacturer	api.fda.gov
Kaz USA, Inc., A Helen of Troy Company	Marlborough, MA, United States	Complaint file establishment, Specification developer	api.fda.gov
Longcheer Meiko Electronics Vietnam Company Limited	Hanoi Ha Noi, Vietnam	Contract manufacturer	api.fda.gov
Luxshare - Ict (nghe An ) Limited	Nghe An, Vietnam	Contract manufacturer	api.fda.gov
Masimo Corporation	Irvine, CA, United States	Complaint file establishment, Specification developer	api.fda.gov
Shanghai Berry Electronic Tech Co., Ltd.	Shanghai, China	Manufacturer	api.fda.gov
Shenzhen Aeon Technology Co.,ltd	shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen BSX Technology Electronics Co.,ltd	Shen Zhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Changkun Technology Co., Ltd.	Shenzhen Guangdong, China	Complaint file establishment, Contract manufacturer, Manufacturer	api.fda.gov
Shenzhen Creative Industry Co., Ltd	SHENZHEN Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Imdk Medical Technology Co., Ltd.	SHENZHEN Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Narig Bio-Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Taikang Medical Equipment Co.,ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Viatom Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Witleaf Medical Electronics Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Yimi Life Technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Yuezhongxing Technology Co.,ltd	Huizhou Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Shenzhen AOJ Medical Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Jumper Medical Equipment Co.,Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Tianjin Choice Medical Device Co., Ltd.	Tianjin, China	Contract manufacturer, Exporter to the US	api.fda.gov
Unika Health Inc.	Sunnyvale, CA, United States	Specification developer	api.fda.gov
Xuzhou Yongkang Electronic Science Technology Co., Ltd	Xuzhou Jiangsu, China	Manufacturer	api.fda.gov
Zhuhai Linte Medical Instrument Co., Ltd.	Zhuhai Guangdong, China	Manufacturer	api.fda.gov
iHealth Labs, Inc.	Sunnyvale, CA, United States	Manufacturer	api.fda.gov

Updated November 2, 2026. 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.