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510(k) Data Aggregation
K Number
K141813Device Name
RHYTHMSTAR SYSTEM
Manufacturer
RHYTHMEDIX, LLC
Date Cleared
2014-08-05
(29 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
RHYTHMEDIX, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RhythmStar system is intended for use by patients who cither have or are at risk of having cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac disease and require cardiac monitoring on a continuing basis. The device continuously records ECG data and upon detection by an ECG analysis algorithm or manually initiated by the patient, automatically delivers the recorded cardiac activity to the server where it is presented and can be reviewed by a medical professional.
The data received from the RhythmStar device can be used by another device for arrhythmia analysis, reporting and signal measurements. The RhythmStar system is not intended to sound any alarms.
The device does not deliver any therapy, administer any drugs, provide interpretive or diagnostic statements or provide for any life support. RhythmStar is for prescription use only.
Device Description
The RhythmStar system consists of the RhythmStar device and the server. The RhythmStar device is a portable, battery-powered, wireless cardiac monitor which may be worn by a patient to record ECG and activity level data for up to 30 consecutive days. The device can capture patient activated and auto-triggered events such as Bradycardia, Tachycardia, and Atrial Fibrillation as identified by an embedded arrhythmia detection algorithm. The device is capable to automatically deliver the data to the server. The data can be delivered to the server wirelessly via mobile network or via USB connection. A medical professional, using the server, can adjust and program the device configuration and auto-triggering parameters.
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