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510(k) Data Aggregation
K Number
K222330Device Name
The Heart Seat
Manufacturer
Date Cleared
2023-04-24
(265 days)
Regulation Number
870.2300Why did this record match?
Applicant Name (Manufacturer) :
Casana Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Heart Seat is a replacement for a standard toilet seat that is indicated for use in a home environment. The Heart Seat is intended to be used for measuring, reviewing and storing non-invasive functional oxygen saturation of arterial hemoglobin (SpO2) and heart rate (HR) in adults of at least 22 years of age with weight ranging from 90 to 350 pounds. Data from the Heart Seat are collected whenever the seat is used and are automatically uploaded to the Casana Cloud where they can be viewed by the healthcare provider. The Heart Seat is not intended for continuous monitoring.
Device Description
The Heart Seat™ is a prescription use remote monitoring system built into a toilet seat. It is intended for physiological monitoring in the home setting. The device and platform are tools intended to support clinicians by providing them with data to help them better manage patients. Monitored users (or Patients) sit on the seat for their data to be captured and sent to the cloud. Clinical users interact with the clinical cloud-based application that provides the patient measurements.
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