River- 1 Electrocardiograph (ecg) Recorder And Transmitter

FDA UDI

Class II (US FDA UDI)

by Shl Telemedicine International Ltd.

Identity

Trade Name: RIVER- 1 ELECTROCARDIOGRAPH (ECG) RECORDER AND TRANSMITTER FDA UDI
Generic Name: Electrocardiograph, home-use FDA UDI
Device Name: The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results. FDA UDI
Model / Reference: E-560-0 / E-561-0 FDA UDI
Description: The Cardio'R is an event recorder that helps physician's document heart problems, which may not be found during a routine ECG examination in a healthcare facility. The device stores the ECG data and transmits it either automatically or manually to a receiving center, which can be a physician's office, hospital or medical center. The receiving center is staffed by healthcare professionals and contains advanced software to convert the data and interpret the results. FDA UDI

Identifiers

Primary DI / UDI-DI: 07290008960267 FDA UDI
510(k) Number: K063609 FDA UDI
FDA Product Code: DXH FDA UDI
GMDN Term: Electrocardiograph, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2920 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 90 Millimeter FDA UDI
Width — 75 Millimeter FDA UDI
Depth — 30 Millimeter FDA UDI
Weight — 200 Gram FDA UDI

Category: Electrocardiograph, home-use

River- 1 Electrocardiograph (ecg) Recorder And Transmitter by Shl Telemedicine International Ltd. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Electrocardiograph, home-use.

ASSURE Wearable ECG — Kestra Medical Technologies, Inc. · Class II
Withings® — Withings SA · Class II
Withings® — Withings SA · Class II
AfibAlert / hom ecg+ — LOHMAN TECHNOLOGIES, LLC · Class II
QT ECG — QT Medical, Inc. · Class II
GEMS Mobile ECG — CardioComm Solutions, Inc · Class II
TelePatch Cardiac Monitor — MEDICOMP, INC. · Class II
KardiaMobile Card — AliveCor · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shl Telemedicine International Ltd.

Sources (1)

FDA UDI 4752d3fc-7d8c-4d67-a947-b699a870c10e 37 fields · synced May 30, 2026