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510(k) Data Aggregation
K Number
K233280Device Name
SteadyTemp
Manufacturer
Date Cleared
2024-06-21
(266 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
SteadySense GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SteadyTemp system is a wireless thermometer intended to provide precise body temperature for users of all ages. The SteadyTemp system comprises a single-use temperature measuring sensor, the SteadySense Patch, and the SteadyTemp application. SteadySense Patch measures and stores axillary skin temperature data up to 10 days. The typical application duration when using the system is 7 days.
Device Description
SteadyTemp is a wireless thermometer designed to provide users of all ages with information about their body temperature. The device has two components, the SteadyTemp app, and the battery operated SteadySense patch. Both are required to measure temperature.
The SteadySense patch is a non-invasive, non-sterile, active temperature measurement device capable of detecting sub-degree (< 0.18°F/ 0.1°C) changes in body temperature by continuously measuring armpit temperature. The SteadySense patch is a disposable bandage product that is applied only to healthy skin under the arm. The top is flexible textile over insulating foam and the bottom is a thin adhesive layer to adhere the thermal sensor to the axilla for measurement recording.
SteadySense temperature measurement is a direct mode, solid state contact temperature transducer embedded in the patch. The patch records up to the last 77 hours of temperature data for download to the SteadyTemp app.
The typical application duration is 7 days. The SteadySense patch continuously records body temperature.
The SteadyTemp app serves as an interface for the user and for interacting with the SteadySense patch and displaying the measured temperature data. The data measured by the patch is transmitted via near-field communication (NFC).
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