DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency Class II
FDA Device Classification
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 |
|---|
| 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 |
| K200690 | lifesignals | LifeSignals ECG Remote Monitoring Patch Platform | July 15, 2020 |