DRG
- Product code
- DRG
- Device name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2910
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 192
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261569 | 2026-07-09 | Lifesignals, Inc. | UbiqVue 2AYe Cardiac System (UX2253) | FDA |
| K252984 | 2026-01-22 | Perin Health Devices, LLC | Perin Health System (PHD80060-2) | |
| K252440 | 2025-10-02 | Ingeniars S.R.L. | EasyTeleMed (2.0.2) | FDA |
| K250259 | 2025-06-04 | The ScottCare Corporation | TeleRehab Aermos Cardiopulmonary Rehabilitation | |
| K243837 | 2025-05-16 | Iorbit Digital Technologies Private Li | iBSM | |
| K242018 | 2024-11-12 | Lifesignals, Inc. | UbiqVue 2A Multi-parameter System (UX2550) | FDA |
| K241101 | 2024-09-26 | Biointellisense, Inc. | BioButton System | |
| K240251 | 2024-06-03 | Sibel Health, Inc. | ANNE Chest | FDA |
Official FDA classification page: DRG
Classification and pathway per current FDA publications. Data from openFDA (CC0).