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US
Last updated May 25, 2026
What UNIVERSAL MEDICAL, INC. makes
Universal Medical, Inc. manufactures electrocardiography (ECG) telemetric monitoring systems, including standalone software solutions and patient monitoring devices. Their portfolio includes systems for remote ECG transmission, such as the Heartrak series, as well as software for data analysis and telephonic ECG transmission. Additional products cover pacemaker monitoring and patient cable accessories for ECG telemetry.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These products are intended for use in the United States, where the manufacturer is based.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Universal Medical, Inc. primarily manufacture?
Universal Medical, Inc. specializes in electrocardiography (ECG) telemetric monitoring systems. These include standalone software solutions like Cardiostation and Heartrak series devices, which enable remote ECG transmission, patient monitoring, and data analysis. The company also produces accessories such as patient cables for ECG telemetry and modules for telephonic ECG transmission.
Where is Universal Medical, Inc. based, and what markets do its devices serve?
Universal Medical, Inc. is based in the United States. Its devices are designed for use in the U.S. market, where they are intended to support cardiac monitoring, remote diagnostics, and telemetry applications in clinical and home settings.
Which regulatory registries list Universal Medical, Inc.’s devices?
Universal Medical, Inc.’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries track Class II medical devices that require premarket notification (510(k)) clearance or UDI compliance under U.S. regulations.
How are Universal Medical, Inc.’s devices classified under FDA regulations?
Universal Medical, Inc.’s devices fall under Class II classification by the FDA. This classification applies to moderate-risk devices that require special controls beyond general controls to ensure safety and effectiveness, such as ECG monitoring systems that require validation of performance and labeling requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 803593073
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Heartrak ECAT 2 | Heartrak ECAT 2 | FDA UDI | Class II | Active |
| Cardiostation Premier Stand Alone Software | Cardiostation Standalone Software | FDA UDI | Class II | Active |
| Heartrak 2 | Heartrak 2 | FDA UDI | Class II | Active |
| Fusion Air | Fusion Air | FDA UDI | Class II | Active |
| eCardiostation Software | eCardiostation Software | FDA UDI | Class II | Active |
| Heartrak Smart Rev 5 | Heartrak Smart Rev 5 | FDA UDI | Class II | Active |
| Pacetrak Plus rev 3 | Pacetrak Plus rev 3 (PP3) | FDA UDI | Class II | Active |
| Heartrak Smart AF | Heartrak Smart AF | FDA UDI | Class II | Active |
| Heartrak ECAT Patient Cable | Heartrak ECAT Patient Cable | FDA UDI | Class II | Active |
| Cardiostation Transtelephonic Module | CardioStation Transtelephonic Module | FDA UDI | Class II | Active |
| Heartrak ECAT | Heartrak ECAT | FDA UDI | Class II | Active |
| Pacetrak Plus Rev 5 | Pacetrak Plus Rev 5(PP5-Pactrak Plus ENR) | FDA UDI | Class II | Active |
| Cardiostation® Advantage Software | Cardiostation® Advantage Software | FDA UDI | Class II | Active |
| Pacetrak Plus rev 4 | Pacetrak Plus rev 4 (PP4-Pacetrak Plus Speaks) | FDA UDI | Class II | Active |
| Heartrak Smart Wireless Rev 1 | Heartrak Smart Wireless Rev 1 | FDA UDI | Class II | Active |
| Heartrak Smart At/Heartrak Smart2 | K033451 | FDA 510(k) | Class II | Active |
| Heartrak Xl | K960499 | FDA 510(k) | Class II | Active |
| Pacetrak | K943123 | FDA 510(k) | Class II | Active |
| Pacetrak Plus | K954495 | FDA 510(k) | Class II | Active |
| Heartrak Smart Ecat | K083535 | FDA 510(k) | Class II | Active |
| Heartrak Af | K071130 | FDA 510(k) | Class II | Active |
| Cardiostation | K980624 | FDA 510(k) | Class II | Active |
| Heartrak | K943124 | FDA 510(k) | Class II | Active |
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