Rhythm Express

GUDID 00860000272407

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.

VIVAQUANT, INC.

Electrocardiography telemetric monitoring system transmitter
Primary Device ID00860000272407
NIH Device Record Key0e8571bc-cb0c-43ea-a87f-09d6b5397a5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameRhythm Express
Version Model NumberRX-1 mini
Company DUNS832287945
Company NameVIVAQUANT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000272407 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-04
Device Publish Date2020-07-27

On-Brand Devices [Rhythm Express]

00860000272414The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a p
00860000272407The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed b

Trademark Results [Rhythm Express]

Mark Image

Registration | Serial
Company
Trademark
Application Date
RHYTHM EXPRESS
RHYTHM EXPRESS
86858342 5200953 Live/Registered
VivaQuant, LLC
2015-12-28
RHYTHM EXPRESS
RHYTHM EXPRESS
76355422 2631573 Dead/Cancelled
Rhythm Express, Inc.
2002-01-05
RHYTHM EXPRESS
RHYTHM EXPRESS
74465044 not registered Dead/Abandoned
Select Entertainment Group, Inc.
1993-12-03

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