Data / Medical devices / United States / Huneo, LLC
Huneo, LLC: FDA-registered device maker in Willoughby Hills, OH, United States, 1 510(k) clearance
Huneo, LLC is registered with the FDA (registration 3047516694) in Willoughby Hills, OH, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2026. Registered through 2026. 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.
- FDA registration number
- 3047516694
- Address
- 35000 Chardon Rd Ste 110, Willoughby Hills, OH, United States, 44094
- Owner or operator
- Huneo, LLC (10096225)
- Roles
- Manufacturer, Specification developer
- First device listed
- July 30, 2026
- Registered through
- 2026
- Brand names listed
- WRAP System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 2 | Manufacturer, 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 |
|---|---|---|---|---|---|---|
| July 15, 2026 | K260050 | WRAP System | MNR | Substantially Equivalent | Huneo, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- All makers of Ventilatory Effort Recorder
Updated July 15, 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.