DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency Class II
FDA product code DRG covers "Transmitters And Receivers, Physiological Signal, Radiofrequency", a Class II medical device regulated under 21 CFR 870.2910. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DRG
- Device Class
- Class II
- Regulation Number
- 870.2910
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261569 | lifesignals | UbiqVue 2AYe Cardiac System (UX2253) | July 9, 2026 |
| K252984 | perin health devices | Perin Health System (PHD80060-2) | January 22, 2026 |
| K252440 | ingeniars | EasyTeleMed (2.0.2) | October 2, 2025 |
| K250259 | scottcare corporation | TeleRehab Aermos Cardiopulmonary Rehabilitation | June 4, 2025 |
| K243837 | iorbit digital technologies private limited | iBSM | May 16, 2025 |
| K242018 | lifesignals | UbiqVue 2A Multi-parameter System (UX2550) | November 12, 2024 |
| K241101 | biointellisense | BioButton System | September 26, 2024 |
| K240251 | sibel health | ANNE Chest | June 3, 2024 |
| K223711 | sibel health | ANNE One | August 10, 2023 |
| K220526 | cardioline | HD+12, HD+15 | May 15, 2023 |
| K223073 | alio | Alio | March 17, 2023 |
| K222398 | vivify health | Care Team Portal | February 6, 2023 |
| K212957 | biolntellisense | BioButton System | December 12, 2022 |
| K221530 | sibel | ANNE Pediatric | November 22, 2022 |
| K212883 | ergoline | ers2 - ergoline Rehabilitation System | July 15, 2022 |
| K213233 | sigknow biomedical co | EZYPRO ECG Recorder (Model: UG02) | June 23, 2022 |
| K211365 | graftworx, inc. dba alio | Alio Medical Remote Monitoring System | March 24, 2022 |
| K211822 | elastic care incorporated | LifePath Remote Patient Monitoring Platform | February 3, 2022 |
| K211305 | sibel | ANNE One | September 14, 2021 |
| K202868 | lifesignals | LifeSignals Multi-Parameter Remote Monitoring Platform | July 21, 2021 |