3 devices · 3 companies · 2017 to 2026
Product code DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency
3 devices under product code DRG, 2017 to 2026, from 3 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Transmitters And Receivers, Physiological Signal, Radiofrequency. 21 CFR 870.2910, Class II. MAUDE held 1,732 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| Perin Health SystemK252984 · 510(k) | Perin Health Devices, LLC | Cardiovascular | database entry | |
| AlioK223073 · 510(k) | Alio, Inc. | Cardiovascular | database entry | |
| Rooti Rx ECG Event Recorder, Rooti Link APP SoftK163694 · 510(k) | Rooti Labs Ltd. | Cardiovascular | database entry |
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