Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2910](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2910) → DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency # DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency _Cardiovascular · 21 CFR 870.2910 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG ## Overview - **Product Code:** DRG - **Device Name:** Transmitters And Receivers, Physiological Signal, Radiofrequency - **Regulation:** [21 CFR 870.2910](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2910) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K252984.md) | Perin Health System (PHD80060-2) | Perin Health Devices, LLC | Jan 22, 2026 | SESE | | [K252440](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K252440.md) | EasyTeleMed (2.0.2) | Ingeniars S.R.L. | Oct 2, 2025 | SESE | | [K250259](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K250259.md) | TeleRehab Aermos Cardiopulmonary Rehabilitation | The ScottCare Corporation | Jun 4, 2025 | SESE | | [K243837](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K243837.md) | iBSM | Iorbit Digital Technologies Private Limited | May 16, 2025 | SESE | | [K242018](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K242018.md) | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | Nov 12, 2024 | SESE | | [K241101](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K241101.md) | BioButton System | Biointellisense, Inc. | Sep 26, 2024 | SESE | | [K240251](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K240251.md) | ANNE Chest | Sibel Health, Inc. | Jun 3, 2024 | SESE | | [K223711](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K223711.md) | ANNE One | Sibel Health, Inc. | Aug 10, 2023 | SESE | | [K220526](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K220526.md) | HD+12, HD+15 | Cardioline S.P.A | May 15, 2023 | SESE | | [K223073](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K223073.md) | Alio | Alio, Inc. | Mar 17, 2023 | SESE | | [K222398](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K222398.md) | Care Team Portal | Vivify Health, Inc. | Feb 6, 2023 | SESE | | [K212957](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K212957.md) | BioButton System | Biolntellisense, Inc. | Dec 12, 2022 | SESE | | [K221530](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K221530.md) | ANNE Pediatric | Sibel, Inc. | Nov 22, 2022 | SESE | | [K212883](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K212883.md) | ers2 - ergoline Rehabilitation System | Ergoline GmbH | Jul 15, 2022 | SESE | | [K213233](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K213233.md) | EZYPRO ECG Recorder (Model: UG02) | Sigknow Biomedical Co., Ltd. | Jun 23, 2022 | SESE | | [K211365](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K211365.md) | Alio Medical Remote Monitoring System | Graftworx, Inc. Dba Alio | Mar 24, 2022 | SESE | | [K211822](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K211822.md) | LifePath Remote Patient Monitoring Platform | Elastic Care Incorporated | Feb 3, 2022 | SESE | | [K211305](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K211305.md) | ANNE One | Sibel, Inc. | Sep 14, 2021 | SESE | | [K202868](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K202868.md) | LifeSignals Multi-Parameter Remote Monitoring Platform | Lifesignals, Inc. | Jul 21, 2021 | SESE | | [K200690](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG/K200690.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRG) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com