Data / Medical devices / Canada / Bowhead Design Corp
Bowhead Design Corp: FDA-registered device maker in Calgary Alberta, Canada, 1 510(k) clearance
Bowhead Design Corp is registered with the FDA (registration 3031658417) in Calgary Alberta, Canada. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031658417
- Address
- 6919 32 Ave NW, Calgary Alberta, Canada, T3B0K6
- Owner or operator
- Bowhead Design Corporation (10092668)
- Roles
- Manufacturer
- First device listed
- February 4, 2025
- Registered through
- 2026
- Brand names listed
- Bowhead Era
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 |
|---|---|---|---|---|---|---|
| January 10, 2025 | K243111 | Bowhead ERA Wheelchairs | IOR | Substantially Equivalent | Bowhead Design Corp. | accessdata.fda.gov |
Compare with other makers
Updated January 10, 2025. 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.