DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency
Cardiovascular · 21 CFR 870.2910 · Class 2
Overview
| Product Code | DRG |
|---|---|
| Device Name | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Regulation | 21 CFR 870.2910 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 191)
Showing 20 most recent of 191 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252984 | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | Jan 22, 2026 | SESE |
| K252440 | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | Oct 2, 2025 | SESE |
| K250259 | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | Jun 4, 2025 | SESE |
| K243837 | iBSM | Iorbit Digital Technologies Private Limited | May 16, 2025 | SESE |
| K242018 | UbiqVue 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | Nov 12, 2024 | SESE |
| K241101 | BioButton System | Biointellisense, Inc. | Sep 26, 2024 | SESE |
| K240251 | ANNE Chest | Sibel Health, Inc. | Jun 3, 2024 | SESE |
| K223711 | ANNE One | Sibel Health, Inc. | Aug 10, 2023 | SESE |
| K220526 | HD+12, HD+15 | Cardioline S.P.A | May 15, 2023 | SESE |
| K223073 | Alio | Alio, Inc. | Mar 17, 2023 | SESE |
| K222398 | Care Team Portal | Vivify Health, Inc. | Feb 6, 2023 | SESE |
| K212957 | BioButton System | Biolntellisense, Inc. | Dec 12, 2022 | SESE |
| K221530 | ANNE Pediatric | Sibel, Inc. | Nov 22, 2022 | SESE |
| K212883 | ers2 - ergoline Rehabilitation System | Ergoline GmbH | Jul 15, 2022 | SESE |
| K213233 | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | Jun 23, 2022 | SESE |
| K211365 | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | Mar 24, 2022 | SESE |
| K211822 | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | Feb 3, 2022 | SESE |
| K211305 | ANNE One | Sibel, Inc. | Sep 14, 2021 | SESE |
| K202868 | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | Jul 21, 2021 | SESE |
| K200690 | LifeSignals ECG Remote Monitoring Patch Platform | Lifesignals, Inc. | Jul 15, 2020 | SESE |
Top Applicants
- Vitalconnect, Inc. — 9 clearances
- American Telecare, Inc. — 5 clearances
- General Devices — 5 clearances
- Honeywell Hommed, LLC — 5 clearances
- Nihon Kohden America, Inc. — 5 clearances
