Data / Medical devices / United States / Neurolumen LLC
Neurolumen LLC: FDA-registered device maker in Oklahoma City, OK, United States, 2 510(k) clearances
Neurolumen LLC is registered with the FDA (registration 3010144038) in Oklahoma City, OK, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 21, 2015. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010144038
- Address
- 9636 N May Ave Ste 230, Oklahoma City, OK, United States, 73120
- Owner or operator
- Neurolumen (10043706)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- March 13, 2013
- Registered through
- 2027
- Brand names listed
- PN-1000
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| January 21, 2015 | K142025 | NEUROLUMEN PN-1000 | ILY | Substantially Equivalent | Neurolumen, LLC | accessdata.fda.gov |
| April 21, 2009 | K082223 | NEUTROLUMENPN SYSTEM, MODEL 1000 | ILY | Substantially Equivalent | Neurolumen, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
Updated January 21, 2015. 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.