Data / Medical devices / United States / Brainmatterz, Inc
Brainmatterz, Inc: FDA-registered device maker in McKinney, TX, United States, 1 510(k) clearance
Brainmatterz, Inc is registered with the FDA (registration 3038274470) in McKinney, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038274470
- Address
- 6710 Virginia Pkwy Ste 215 Pmb 12, McKinney, TX, United States, 75071
- Owner or operator
- BrainMatterZ, Inc (10093071)
- Roles
- Manufacturer
- First device listed
- March 26, 2025
- Registered through
- 2026
- Brand names listed
- BrainMatterZ HST Patch, BrainMatterZ System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Manufacturer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 1, 2023 | K223676 | SomniCheck | GWL | Substantially Equivalent | Brainmatterz, LLC | accessdata.fda.gov |
Compare with other makers
Updated June 1, 2023. 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.