Oximeter, Infrared, Sporting, Aviation
Cardiovascular · 21 CFR 870.2700
Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.
Recent MDR events
35 adverse event reports on file
- MedlineJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08106
- MedlineJul 31, 2026MalfunctionMedline Industries, Lp1417592-2026-08108
- MedlineJul 30, 2026MalfunctionMedline Industries, Lp1417592-2026-08077
- MedlineJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07895
- MedlineJul 28, 2026MalfunctionMedline Industries, Lp1417592-2026-07943
- MEDLINEJul 21, 2026MalfunctionMedline Industries, Lp1417592-2026-07120
- MEDLINEJul 12, 2026MalfunctionMedline Industries, Lp1417592-2026-05161
- MEDLINEJul 11, 2026MalfunctionMedline Industries, Lp1417592-2026-05150
- MEDLINEJul 7, 2026MalfunctionMedline Industries, Lp1417592-2026-04616
- MEDLINEJul 1, 2026MalfunctionMedline Industries, Lp1417592-2026-03770
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
60 firms currently registered for this product code
Sunset Healthcare Solutions, Inc.
CHICAGO, IL, US
Masimo Corporation
Irvine, CA, US
Tianjin Choice Medical Device Co., Ltd.
Tianjin, CN
Guangdong Health Tree Medical Technology Co., Ltd.
Zhuhai Guangdong, CN
Shenzhen Narig Bio-medical Technology Co., Ltd.
Shenzhen Guangdong, CN
Andon Health Co., Ltd
TIANJIN, CN
Shenzhen Taikang Medical Equipment Co.,ltd.
Shenzhen Guangdong, CN
Longcheer Meiko Electronics Vietnam Company Limited
Hanoi Ha Noi, VN
Golden Smart Home Technology Corp.
Hsinchu City Hsinchu (City), TW
Shenzhen Witleaf Medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
Fka Distributing Co., Llc
Riverside, CA, US
Giantsun Power Electronics (vietnam) Co., Ltd
Hanoi Ha Noi, VN
Amarigo Inc
Los Angeles, CA, US
Easy Healthcare Corporation
Darien, IL, US
Beijing Choice Electronic Technololgy Co., Ltd.
BEIJING, CN
Shenzhen Imdk Medical Technology Co., Ltd.
SHENZHEN Guangdong, CN
Mandarin Enterprises, Llc
Atlanta, GA, US
Luxshare - Ict (nghe An ) Limited
Nghe An, VN
Zhuhai Linte Medical Instrument Co., Ltd.
Zhuhai Guangdong, CN
Thermor Ltd.
Newmarket Ontario, CA
Shenzhen Aeon Technology Co.,ltd
shenzhen Guangdong, CN
Jiangxi Aicare Medical Technology Co., Ltd
Fuzhou Jiangxi, CN
Beijing Choicemmed Technology Co., Ltd.
Beijing, CN
Guangzhou Berrcom Medical Device Co., Ltd
Guangzhou Guangdong, CN
Ihealth Labs, Inc.
Sunnyvale, CA, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.