Rooti Rx ECG Event Recorder

JSON twin: https://www.healthaidb.com/software/rooti-rx-ecg-event-recorder.json

Company Name

Rooti Labs

Product URL

https://rootilabs.com

Company URL

https://rootilabs.com

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

Rooti Rx ECG Event Recorder is a wearable device that enables patients to record single-lead ECG data for remote monitoring by healthcare professionals.

Description

Rooti Rx ECG Event Recorder is a compact, single-lead ECG recording device designed for home and workplace use. It allows patients to record ECG data, which is stored locally and transmitted via Wi-Fi to medical professionals' iOS devices for post-analysis, aiding in patient cardiac monitoring and diagnosis. The device is intended for general care patients aged 21 and older and is not suitable for critical care patients. It is FDA registered with 510(k) number K163694 and has received CE certification (EC Certificate Full Quality Assurance System FI16/07021).

Api Available

no

Certifications

• FDA 510(k) clearance (K163694)
• CE Marking (FI16/07021)
• TFDA approval (005772)
• ARTG registration (300643)

Company Founding

2014

Company Offices

• Taiwan
• United States
• European Union

Compliance

• FDA 510(k) clearance (K163694)
• CE Marking (FI16/07021)
• TFDA approval (005772)
• ARTG registration (300643)

Customers

Data Residency

Data stored on device; transmitted via Wi-Fi to iOS devices

Data Standards

• ECG data format

Deployment Model

• SaaS

Features

• Single-lead ECG recording
• Continuous monitoring up to 7 days
• Wi-Fi data transmission to iOS devices
• Real-time ECG measurement (30-second or 5-minute intervals)
• ECG data storage on device
• Motion sensor for activity tracking
• Water-resistant (IP58 rating)
• Lightweight design (14 grams)
• Rooti Link app for data download and review
• Rooti Kiosk app for real-time ECG measurement
• Preview mode for signal verification
• Automated report generation
• Easy setup with instructional tutorials
• LED indicators for device status
• Rechargeable battery with USB charging
• Compatible with standard disposable ECG electrodes
• Event tagging feature for user-initiated recordings
• Data analysis and health report generation
• User-friendly interface for both patients and healthcare providers

Id

SW0604

Integration Partners

Integrations

• iOS devices
• Rooti Link app
• Rooti Kiosk app

Languages Supported

• English
• Dutch
• French
• German
• Italian
• Japanese
• Korean
• Simplified Chinese
• Spanish
• Traditional Chinese
• Turkish

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Rooti Link app
• Rooti Kiosk app

Os Platforms

• iOS
• iPadOS

Pricing Details

Contact vendor

Pricing Model

Contact vendor

Privacy Features

• Data storage on device
• Event tagging feature for user-initiated recordings
• Automated report generation

Product Code

SW0604

Product Name

Rooti Rx ECG Event Recorder

Ratings

Regions Available

• United States
• European Union
• Taiwan

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Wi-Fi data transmission
• LED indicators for device status
• User authentication for app access

Specialties

• Cardiology

Support Channels

System Requirements

iOS 9.0 or later

Target Users

• Clinicians
• Patients

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Rooti Rx ECG Event Recorder",
  "company_name": "Rooti Labs",
  "product_url": "https://rootilabs.com",
  "company_url": "https://rootilabs.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0604",
  "summary": "Rooti Rx ECG Event Recorder is a wearable device that enables patients to record single-lead ECG data for remote monitoring by healthcare professionals.",
  "description": "Rooti Rx ECG Event Recorder is a compact, single-lead ECG recording device designed for home and workplace use. It allows patients to record ECG data, which is stored locally and transmitted via Wi-Fi to medical professionals' iOS devices for post-analysis, aiding in patient cardiac monitoring and diagnosis. The device is intended for general care patients aged 21 and older and is not suitable for critical care patients. It is FDA registered with 510(k) number K163694 and has received CE certification (EC Certificate Full Quality Assurance System FI16/07021).",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Clinicians",
    "Patients"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States",
    "European Union",
    "Taiwan"
  ],
  "languages_supported": [
    "English",
    "Dutch",
    "French",
    "German",
    "Italian",
    "Japanese",
    "Korean",
    "Simplified Chinese",
    "Spanish",
    "Traditional Chinese",
    "Turkish"
  ],
  "pricing_model": "Contact vendor",
  "pricing_details": "Contact vendor",
  "license": "Commercial",
  "company_offices": [
    "Taiwan",
    "United States",
    "European Union"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "iOS",
    "iPadOS"
  ],
  "features": [
    "Single-lead ECG recording",
    "Continuous monitoring up to 7 days",
    "Wi-Fi data transmission to iOS devices",
    "Real-time ECG measurement (30-second or 5-minute intervals)",
    "ECG data storage on device",
    "Motion sensor for activity tracking",
    "Water-resistant (IP58 rating)",
    "Lightweight design (14 grams)",
    "Rooti Link app for data download and review",
    "Rooti Kiosk app for real-time ECG measurement",
    "Preview mode for signal verification",
    "Automated report generation",
    "Easy setup with instructional tutorials",
    "LED indicators for device status",
    "Rechargeable battery with USB charging",
    "Compatible with standard disposable ECG electrodes",
    "Event tagging feature for user-initiated recordings",
    "Data analysis and health report generation",
    "User-friendly interface for both patients and healthcare providers"
  ],
  "optional_modules": [
    "Rooti Link app",
    "Rooti Kiosk app"
  ],
  "integrations": [
    "iOS devices",
    "Rooti Link app",
    "Rooti Kiosk app"
  ],
  "data_standards": [
    "ECG data format"
  ],
  "api_available": "no",
  "system_requirements": "iOS 9.0 or later",
  "compliance": [
    "FDA 510(k) clearance (K163694)",
    "CE Marking (FI16/07021)",
    "TFDA approval (005772)",
    "ARTG registration (300643)"
  ],
  "certifications": [
    "FDA 510(k) clearance (K163694)",
    "CE Marking (FI16/07021)",
    "TFDA approval (005772)",
    "ARTG registration (300643)"
  ],
  "security_features": [
    "Wi-Fi data transmission",
    "LED indicators for device status",
    "User authentication for app access"
  ],
  "privacy_features": [
    "Data storage on device",
    "Event tagging feature for user-initiated recordings",
    "Automated report generation"
  ],
  "data_residency": "Data stored on device; transmitted via Wi-Fi to iOS devices",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0604",
  "slug": "rooti-rx-ecg-event-recorder",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/rooti-rx-ecg-event-recorder.json"
  }
}