Home › Device types › DRG
Transmitters And Receivers, Physiological Signal, Radiofrequency
FDA product code DRG · Class 2 · Cardiovascular
629
Registered devices
1,732
Adverse events
12
Recalls
192
510(k) clearances
Devices with this code
Vivifyhealth Kit 002 — Vivify Health, Inc.PORTRAIT SpO2 P-SA01 — GE Healthcare Finland OyER920W First-Call Medical — BRAEMAR MANUFACTURING, LLCTeleRehab Receiver Box — SCOTTCARE CORPORATION, THEAvalon Toco+ Transducer — Philips Medizin Systeme Böblingen GmbHNA — NIHON KOHDEN CORPORATIONVivifyhealth Kit 003 — Vivify Health, Inc.ANNE Limb Sensor — Sibel Health Inc.BluPRO® — NIHON KOHDEN CORPORATIONVital Sync — Covidien LPNA — NIHON KOHDEN AMERICA, INC.Vivifyhealth SK004 — Vivify Health, Inc.Portrait CSSXB — GE Medical Systems Information Technologies, Inc.Surveyor Patient Cable — MORTARA INSTRUMENT, INC.Genesis DM w ST NIBP 2 — Mobilehelp, LLCBluPRO® — NIHON KOHDEN CORPORATIONVista Solution® 2.0 10-day Evaluation Kit — Vital Connect, Inc.Surveyor S4 — MORTARA INSTRUMENT, INC.Surveyor S4 — MORTARA INSTRUMENT, INC.IDEAL LIFE BP-Manager™ — Ideal Life IncBluPRO® — NIHON KOHDEN CORPORATIONVitalPatch™ 2.0 Single — Vital Connect, Inc.Empatica Health Monitoring Platform — EMPATICA SRLWVSM Wireless Vital Signs Monitor — ATHENA GTX, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-20 | Midmark Corporation | A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation. |
| 2024-07-19 | Biointellisense Inc. | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. |
| 2021-01-08 | Nihon Kohden America Inc | Incorrect Date Stamp or No Data Transfer on Telemetry Receiver and Transmitter. |
| 2020-05-21 | Vitalconnect Inc. | A healthcare provider (HCP) noticed a patient had a lowered historic SpO2 reading that the software should have triggered a notification to the care team, but n |
| 2017-05-15 | Boston Scientific Corporation | The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing. |
| 2017-03-02 | Philips Visicu | eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation, storage and clinical information management with independent |
| 2016-03-10 | Philips Visicu | The adherence check generates a software error. Two issues occur as a result of the software error: 1) No adherence flag is generated for that day; 2) No task i |
| 2012-02-24 | BRAEMAR, INC. | Braemar has recently became aware of a battery related incident that occurred with EWT battery packs that are used in a Braemer ER920W wireless event monitor an |
| 2011-05-02 | BRAEMAR, INC. | Braemar Inc., became aware of a battery related incident that occurred with an Able battery pack being used in a Braemar ER920W wireless event monitor. The ev |
| 2007-12-13 | Lifesync Corporation | LifeSync Wireless ECG System - Intermittent failure when using LS-202 and LS-232 LeadWear in conjunction with LS-41245 and LS-41285 Adaptors. The out of box fa |
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