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510(k) Data Aggregation
K Number
K173730Device Name
Kinsa QuickCare Thermometer
Manufacturer
KINSA, Inc.
Date Cleared
2018-01-17
(42 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
KINSA, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kinsa QuickCare Thermometer is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm. The device is for the adult and pediatric population.
Device Description
The Kinsa QuickCare Thermometer is a battery powered, thermistor based predictive Bluetooth low energy (BLE) enabled thermometer used for the measurement and monitoring of human body temperature. Body temperature can be measured with the Kinsa QuickCare Thermometer orally, axillary (under the arm), and rectally. The thermometer is reusable for clinical and/or home use on people of all ages with adult supervision. The device can be used with as a standalone device or in conjunction with the Kinsa App on a compatible BLE enabled smartphone.
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K Number
K132514Device Name
KINSA SMART THERMOMETER
Manufacturer
KINSA, INC.
Date Cleared
2013-12-02
(112 days)
Product Code
FLL, CLI
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
KINSA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Kinsa Smart Thermometer is intended to measure the human body temperature orally, rectally, or under the arm, and the devices are reusable for clinical or home use on people of all ages.
Device Description
The Kinsa Smart Thermometer product is a thermometer that connects to a Smartphone or another mobile device (e.g. an iPod Touch). The product will read body temperature the same way a clinical digital thermometer does by being placed under the tongue in the mouth, rectum or alternatively, or under the arm. Like other clinical digital thermometers, the Kinsa Smart Thermometer is a thermistor-based product; however, it has the advantage of being read on a mobile device display. Unlike other clinical digital thermometers, the Kinsa Smart Thermometer product requires no batteries or LCD displays. The Kinsa Smart Thermometer is reusable for clinical or home use on people of all ages.
The Kinsa Smart Thermometer will connect to Smartphones or other mobile devices via a headphone jack that accepts a microphone input. In this document the terms Smartphone, smartohone and mobile device are used interchangeably and are defined to include the following products: Apple iPhones 5, 4S and the Apple iPod Touch 5.
The Kinsa Smart Thermometer consists of four components:
- A. Thermometer (probe).
- B. An adapter to setup each Smartphone for temperature reading (only needed once per Smartphone).
- C. An optional, flexible extension cord that can be used to lengthen the distance between the thermometer and Smartphone so users can see the Smartphone screen while taking a temperature.
- D. Software.
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