Data / Medical devices / United States / Fainteer Limited
Fainteer Limited: FDA-registered device maker in Littleton, CO, United States, 2 510(k) clearances
Fainteer Limited is registered with the FDA (registration 3031506335) in Littleton, CO, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 13, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031506335
- Address
- 5306 S Bannock St Ste 207, Littleton, CO, United States, 80120
- Owner or operator
- Fainteer Limited (10090514)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- April 7, 2024
- Registered through
- 2026
- Brand names listed
- Expiratory Breathing Exerciser, Nebulizer, Portable Nebulizer, Ultrasonic Nebulizer, Nebulizer Machine for Adults &Kids, OTC Pulse Oximeter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Pulse Oximeter For Over-The-Counter Use | OLK | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pump, Nebulizer, Electrically Powered | JPW | 1 | Manufacturer | accessdata.fda.gov |
| Spirometer, Therapeutic (Incentive) | BWF | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 13, 2024 | K211498 | Nonin OTC Pulse Oximeter Model 3250 | OLK | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| January 13, 1995 | K945118 | EXPIRATORY BREATHING EXERCISER | BWF | Substantially Equivalent | Dhd Diemolding Healthcare Div. | accessdata.fda.gov |
Compare with other makers
- All makers of Pump, Nebulizer, Electrically Powered
- All makers of Spirometer, Therapeutic (Incentive)
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated November 13, 2024. 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.