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Sign in to claim this brandRhythMedix, LLC
US
Last updated May 31, 2026
What RhythMedix, LLC makes
RhythMedix, LLC manufactures electrocardiography telemetric monitoring systems designed for continuous or remote cardiac rhythm assessment. These devices are intended for clinical or ambulatory use to capture and transmit ECG data for diagnostic evaluation.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identification (UDI) databases. The manufacturer is based in the United States.
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 RhythMedix, LLC manufacture?
RhythMedix, LLC specializes in electrocardiography telemetric monitoring systems. These devices are designed for continuous or remote cardiac rhythm assessment, allowing for real-time or delayed ECG data capture and transmission. They are primarily intended for clinical or ambulatory settings to aid in diagnostic evaluations of heart rhythms.
Where is RhythMedix, LLC based?
RhythMedix, LLC is headquartered in the United States. The company’s location is relevant for regulatory compliance and reporting purposes, as it operates under U.S. medical device regulations.
Which regulatory registries list RhythMedix, LLC’s devices?
RhythMedix, LLC’s devices are included in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries track Class II devices that require regulatory clearance before commercial distribution in the U.S.
How are RhythMedix, LLC’s devices classified under FDA regulations?
RhythMedix, LLC’s electrocardiography telemetric monitoring systems fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- rhythmedix.com
- —
- —
- [email protected]
- Phone
- (856) 282-1080
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 058907377
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RhythmStar | RS-10002V | FDA UDI | Class II | Active |
| RhythmStar | RS-10002 | FDA UDI | Class II | Active |
| RhythmStar | RS-10003 | FDA UDI | Class II | Active |
| RhythmStar System (SL) | K250793 | FDA 510(k) | Class II | Active |
| Rhythmstar System | K141813 | FDA 510(k) | Class II | Active |
| RhythmStar System | K233584 | FDA 510(k) | Class II | Active |
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