Data / Medical devices / Transmitters And Receivers, Physiological Signal, Radiofrequency
Transmitters And Receivers, Physiological Signal, Radiofrequency (DRG): 95 FDA-registered makers in 23 countries
95 establishments in 23 countries are registered with the FDA to make Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG, Class 2, 21 CFR 870.2910). 33 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 192 510(k) clearances under this code, the latest on July 9, 2026, and lists 11 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- DRG
- Device class
- 2
- Regulation
- 870.2910
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 47 |
| China | 8 |
| Germany | 5 |
| Taiwan | 5 |
| United Kingdom | 4 |
| Japan | 3 |
| India | 3 |
| Italy | 2 |
| Switzerland | 2 |
| South Korea | 2 |
| Mexico | 2 |
| Costa Rica | 1 |
| Israel | 1 |
| Thailand | 1 |
| Netherlands | 1 |
| Romania | 1 |
| Vietnam | 1 |
| Finland | 1 |
| Austria | 1 |
| Sweden | 1 |
| Bulgaria | 1 |
| Indonesia | 1 |
| Brazil | 1 |
Makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| LifeSignals, Inc. | Milpitas, CA, United States | Complaint file establishment, Specification developer | 4 | July 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Sibel Health Inc. | Chicago, IL, United States | Manufacturer | 4 | June 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biointellisense Inc. | Redwood City, CA, United States | Manufacturer, Specification developer | 3 | September 26, 2024 | 0 | 1 | 0 | api.fda.gov |
| Biointellisense Inc. | Golden, CO, United States | Manufacturer, Repackager or relabeler | 3 | September 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Carematix Inc. | Chicago, IL, United States | Manufacturer, Specification developer | 3 | May 5, 2010 | 0 | 0 | 0 | api.fda.gov |
| Scottcare Corporation | Cleveland, OH, United States | Manufacturer, Manufacturer for export | 2 | June 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer, Repackager or relabeler | 2 | December 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| VitalConnect, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor | 2 | April 20, 2020 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 1 | March 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Manufacturer | 1 | March 24, 2017 | 0 | 0 | 0 | api.fda.gov |
| Caretaker Medical | Charlottesville, VA, United States | Manufacturer, Specification developer | 1 | October 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 1 | June 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Cardioline S.P.A. | Trento, Italy | Manufacturer | 1 | May 15, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cerner Corporation | Kansas City, MO, United States | Complaint file establishment, Manufacturer | 1 | November 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 1 | June 21, 2006 | 0 | 0 | 0 | api.fda.gov |
| Ergoline GMBH | BITZ Baden-Wurttemberg, Germany | Manufacturer | 1 | July 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Specification developer | 1 | March 13, 2009 | 0 | 0 | 0 | api.fda.gov |
| LifeSync Corporation | Coral Springs, FL, United States | Specification developer | 1 | August 5, 2003 | 0 | 2 | 0 | api.fda.gov |
| Medicomp, Inc. | Melbourne, FL, United States | Specification developer | 1 | December 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 1 | June 29, 2007 | 0 | 1 | 0 | api.fda.gov |
| Nihon Kohden Corp. | SHINJUKU-KU Tokyo, Japan | Specification developer | 1 | June 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Tomioka Production Center | TOMIOKA-SHI Gunma, Japan | Manufacturer | 1 | June 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer | 1 | June 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center | Tokorozawa Saitama, Japan | Complaint file establishment, Specification developer | 1 | June 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Oracle Cerner Healthcare Solutions India Private Limited | Bangalore Karnataka, India | Manufacturer | 1 | November 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Philips Medizin Systeme Boeblingen GmbH | BOEBLINGEN Baden-Wurttemberg, Germany | Complaint file establishment, Manufacturer, Specification developer | 1 | November 26, 2013 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 1 | April 16, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sigknow Biomedical Co., Ltd. | Taipei City, Taiwan | Manufacturer | 1 | June 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 1 | May 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | May 3, 2012 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Specification developer | 1 | October 21, 2011 | 0 | 0 | 0 | api.fda.gov |
| Taidoc Technology Corporation | New Taipei City, Taiwan | Contract manufacturer, Manufacturer | 1 | January 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| Vivalnk, Inc. | Campbell, CA, United States | Manufacturer, Specification developer | 1 | January 7, 2020 | 0 | 0 | 0 | api.fda.gov |
| All Quality & Services, Inc. | Fremont, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| All Quality & Services, Inc. | Garland, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Athena GTX | Johnston, IA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avita (wujiang) Co., Ltd | Wujiang City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Westford, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | El Coyol Alajuela, Costa Rica | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ActiGraph L.L.C. | Pensacola, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biobeat Technologies Ltd | Petakh Tikva Central, Israel | Exporter to the US, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boyd Technologies (Thailand) Co., Ltd. | Amphur Muang Chonburi Chon Buri, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chero Technology Co., Ltd. | Jiaxing Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corsano Health B.V. | The Hague Zuid-Holland, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cicor Medtec Bucharest | Bucharest Bucuresti, Romania | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Corsano Health SA | Plan-les-Ouates Geneve, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation dba MT. OLIVE MFG | Mooresville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Current Health Ltd | Edinburgh Edinburgh, City of, United Kingdom | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Co., Ltd. | Asan-si Chungnam, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dreamtech Vietnam Co., Ltd | Tu Son Ward Bac Ninh, Vietnam | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dynamic Ems Ltd | Dalgety Bay Fife, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan CFE Electronic Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Edan Instruments, Inc. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EMPATICA S.r.l. | Milano, Italy | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ever Ppe Inc | Sealy, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Healthcare Finland OY | HELSINKI Uusimaa, Finland | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V. | JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GWW | Gaertringen Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Happy Health | Austin, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hinlab Inc. | Lewes, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intops Co.,ltd. | Suwon Gyeonggi, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key-Tech Scotland Ltd | Dunfermline Fife, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Leonhard Lang GMBH | INNSBRUCK Tirol, Austria | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals India Private Limited | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linxens Healthcare (Tianjin) Co., Ltd | JinNan District Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Linxens Sweden AB | Angelholm Skane, Sweden | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medeia Group Ltd | Sofia Sofia-Grad, Bulgaria | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Murata Vios, Inc. | Woodbury, MN, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Murata Vios, Private Limited | Kodihalli, Bangalore Karnataka, India | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nicolay GMBH | NAGOLD Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ontogen Manufacturing LLC | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Printec H.T. Electronics Corp. | New Taipei City 235, Taiwan (R.O.C.), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PT Giken Precision Indonesia | Batam Riau, Indonesia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulsion Medical Systems Se | Aschheim, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Ltda | Varginha Minas Gerais, Brazil | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Andover, MA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Remote Diagnostic Technologies Ltd. | FARNBOROUGH Hampshire, United Kingdom | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Smartcardia SA | Lausanne Vaud, Switzerland | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Mindray Bio-Medical Electronics Co.,LTD | SHENZHEN Guangdong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taiwan Aulisa Medical Devices Technologies, Inc. | Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Velcromex, S.A. De C.V. | AGUA PRIETA Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wistron Medical Technology Corporation | Zhubei City Hsinchu(County), Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated July 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.