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Sign in to claim this brandIRHYTHM TECHNOLOGIES, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 699 8th Street, San Francisco, CA, 94103
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3007208829
- DUNS Number
- 861237670
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ZEUS Platform (FG0501US) | K252859 | FDA 510(k) | Class II | Active |
| ZIO XT Patch | N100A102X | FDA UDI | Class II | Active |
| Zio ECG Utilization Software (ZEUS) System | FG0401US | FDA UDI | Class II | Active |
| Zio monitor | DFG0001 | FDA UDI | Class II | Active |
| ZIO AT Patch | A100A100X | FDA UDI | Class II | Active |
| ZIO SR Patch | K100A101X | FDA UDI | Class II | Unknown |
| Zeus (zio Ecg Utilization Service) System | K091075 | FDA 510(k) | Class II | Active |
| Zio Patch, Model Z100 | K090363 | FDA 510(k) | Class II | Active |
| ZEUS System (Zio Watch) | K213409 | FDA 510(k) | Class II | Active |
| ZEUS System | K222389 | FDA 510(k) | Class II | Active |
| Zio AT ECG Monitoring System | K163512 | FDA 510(k) | Class II | Active |
| Zio XT ECG Monitoring System, Zio AT ECG Monitoring System | K190593 | FDA 510(k) | Class II | Active |
| Ecard And Ccard | K081471 | FDA 510(k) | Class II | Active |
| Zio Patch | K121319 | FDA 510(k) | Class II | Active |
| Zio® monitor (DFG0001) | K243650 | FDA 510(k) | Class II | Active |
| ZEUS (ZIO ECG Utilization Service) System | K142681 | FDA 510(k) | Class II | Active |
| Zio Patch | K113862 | FDA 510(k) | Class II | Active |
| Zio AT® device (A100A1001) | K240177 | FDA 510(k) | Class II | Active |
| ZIO SR ECG Monitoring Service | K143513 | FDA 510(k) | Class II | Active |
| Zio AT® device (A100A1001) | K240029 | FDA 510(k) | Class II | Active |
| Zio ECG Utilization Software (ZEUS) System | K202527 | FDA 510(k) | Class II | Active |
| Zio AT ECG Monitoring System, ZEUS System | K181502 | FDA 510(k) | Class II | Active |
| Zio Monitor | K202359 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 28, 2022 | Z-0183-2023 | — | open, classified | Ambulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete; 2) Patches limited to 100 symptomatic and 500 asymptomatic wireless transmissions; once the maximum transmission limit is reached for either type, any further transmissions for that type will cease. Risk of delayed reporting to health providers. |