Data / Medical devices / Netherlands / Huka B.V.
Huka B.V.: FDA-registered device maker in Oldenzaal Overijssel, Netherlands, 1 510(k) clearance
Huka B.V. is registered with the FDA (registration 3005150489) in Oldenzaal Overijssel, Netherlands. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 24, 1991. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005150489
- Address
- Munsterstraat 13, Oldenzaal Overijssel, Netherlands, 7575 ED
- Owner or operator
- Huka B.V. (9072816)
- Roles
- Manufacturer
- First device listed
- November 14, 2007
- Registered through
- 2026
- Brand names listed
- huka
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wheelchair, Mechanical | IOR | 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 |
|---|---|---|---|---|---|---|
| October 24, 1991 | K913759 | DUET BICYCLE/WHEELCHAIR | IOR | Substantially Equivalent | Robert Hoening Mobility Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 24, 1991. 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.