VIVAQUANT, INC.

Address:1265 Grey Fox Rd,Arden Hills,MN,55112,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Transmitters And Receivers, Electrocardiograph, Telephone (DXH) (2)

Premarket Exempt

Clear

Rhythm Express - 00860000272407 Catalog Number :

Device Description : The Rhythm Express RX-1 mini will be worn by adult patients for a period of time The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 mini will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 mini incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 mini device uses an embedded cellular modem on the cellular network.The RX-1 mini device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

Device Class : 2

Duns Number: 832287945

Premarket Exempt : No

Product Code : DXH

Prescription Use : Yes

Device Count : 1

Rhythm Express - 00860000272414 Catalog Number :

Device Description : The Rhythm Express RX-1 will be worn by adult patients for a period of time as p The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network.The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.