Data / Medical devices / Device, Biofeedback / United States
FDA-registered makers of Device, Biofeedback in the United States: 49 establishments
49 establishments in the United States are registered with the FDA to make Device, Biofeedback (product code HCC). 11 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Device, Biofeedback
- Product code
- HCC
- Country
- United States
Makers of Device, Biofeedback in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Freespira, Inc | Kirkland, WA, United States | Complaint file establishment, Manufacturer, Remanufacturer, Specification developer | 2 | August 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| The Prometheus Group | Dover, NH, United States | Manufacturer, Repackager or relabeler | 2 | December 17, 1997 | 0 | 0 | 0 | api.fda.gov |
| Control Bionics Inc. | Milford, OH, United States | Manufacturer | 1 | January 21, 1986 | 0 | 0 | 0 | api.fda.gov |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 1 | February 1, 2008 | 0 | 0 | 0 | api.fda.gov |
| Eclosion | Fairlawn, OH, United States | Manufacturer | 1 | October 13, 1989 | 0 | 0 | 0 | api.fda.gov |
| EEG Software LLC | Gainesville, FL, United States | Complaint file establishment, Manufacturer | 1 | February 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| International Health Technologies | Salt Lake City, UT, United States | Manufacturer | 1 | March 14, 1996 | 0 | 0 | 0 | api.fda.gov |
| Myotronics-Noromed, Inc. | Kent, WA, United States | Manufacturer | 1 | November 13, 2001 | 0 | 0 | 0 | api.fda.gov |
| Neolight, LLC | Scottsdale, AZ, United States | Complaint file establishment, Specification developer | 1 | December 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| NFANT LABS Inc | Port Richey, FL, United States | Manufacturer | 1 | September 9, 2015 | 0 | 0 | 0 | api.fda.gov |
| Synaptic Tech, LLC | Los Angeles, CA, United States | Manufacturer | 1 | August 4, 1995 | 0 | 0 | 0 | api.fda.gov |
| Accelerated Care Plus Corp. | Reno, NV, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amaze Neuro, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avazzia, Inc. | Dallas, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altivera Medical, Inc. | Englewood, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brainmaster Technologies, Inc. | Bedford, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CIONIC Facility | Scotts Valley, CA, United States | Remanufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clarity Design, Inc. | Poway, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clearlake-Tech Inc | Clear Lake, SD, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Co-Ax Technology, Inc. | Solon, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Delsys Inc. | Natick, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Djo, LLC | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dymedix Diagnostics Inc | Shoreview, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drive Northpoint, LLC | Palmetto, GA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmonic Energetic Technologies, LLC | Liverpool, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Holistic Technologies LLC | Milton, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Incontrol Medical, LLC | Pewaukee, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jogo Health | Bridgewater, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lief Device Facility | Berkeley, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medrhythms, Inc. | Portland, ME, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medspira LLC | Minneapolis, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mtrigger, LLC | Newark, DE, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Myomo, Inc. | Burlington, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Noraxon Usa, Inc. | Scottsdale, AZ, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ochs Labs, LLC | Sebastopol, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ondamed Inc. | Washingtonville, NY, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| PsyTechVR, Inc. | Frederick, MD, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RB Enterprise Co., Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Relevium Labs, Incorporated | Oxford, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Inc. | Murrysville, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SRS Medical | Chelmsford, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Storyup, Inc. Dba Healium | Columbia, MO, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Semi-Kinetics, Inc. OBO SK Global Trading Inc. | Lake Forest, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Think Interfaces LLC | Lakeway, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| TT Electronics | Perry, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VISPALEXO, INC dba UBILITY | North Canton, OH, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| White Dove Global Marketing, Ltd | Commerce Township, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.