Data / Medical devices / United States / Neurotron Medical
Neurotron Medical: FDA-registered device maker in Warminster, PA, United States, 2 510(k) clearances
Neurotron Medical is registered with the FDA (registration 2245302) in Warminster, PA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 20, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2245302
- Address
- 1520 Campus Drive Unit K, Warminster, PA, United States, 18974
- Owner or operator
- NEUROTRON MEDICAL dba NEUMED (9035553)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 13, 2006
- Registered through
- 2026
- Brand names listed
- ORTHOFECT, THERAKNIT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Media, Electroconductive | GYB | 2 | Repackager or relabeler | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | 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 |
|---|---|---|---|---|---|---|
| December 20, 2005 | K053214 | THERAKNIT GARMENT ELECTRODE | GXY | Substantially Equivalent | Neurotron Medical | accessdata.fda.gov |
| July 27, 1978 | K780973 | SIGNAPAD | GYB | Substantially Equivalent | Parker Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Media, Electroconductive
- All makers of Orthosis, Limb Brace
- All makers of Electrode, Cutaneous
Updated December 20, 2005. 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.