Data / Medical devices / Spain / Novaf Andalucia 2007, S.L.
Novaf Andalucia 2007, S.L.: FDA-registered device maker in Rota Cadiz, Spain, 1 510(k) clearance
Novaf Andalucia 2007, S.L. is registered with the FDA (registration 3009560097) in Rota Cadiz, Spain. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 6, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009560097
- Address
- Pol. Ind. Santa Teresa, nave 1 Aptado de correos 173, Rota Cadiz, Spain, 11520
- Owner or operator
- Novaf Andalucia 2007, S.L. (10040264)
- Roles
- Manufacturer
- First device listed
- March 26, 2012
- Registered through
- 2026
- Brand names listed
- Andador Walker, Bed Grip, Muletas Anfibias, Oceanic
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Wheelchair | KNO | 1 | Manufacturer | accessdata.fda.gov |
| Crutch | IPR | 1 | Manufacturer | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Manufacturer | accessdata.fda.gov |
| Wheelchair, Special Grade | IQC | 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 |
|---|---|---|---|---|---|---|
| July 6, 2012 | K120302 | MECHANICAL WHEELCHAIR | IQC | Substantially Equivalent | Novaf Andalucia 2007, SL | accessdata.fda.gov |
Compare with other makers
Updated July 6, 2012. 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.