Bowhead Design Corp.
CanadaFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Bowhead Design Corp. makes
Bowhead Design Corp. makes push-rim manual wheelchairs, specifically non-bariatric models such as the Bowhead Era and Bowhead ERA Wheelchairs. These products are designed for manual propulsion by the user.
The company's portfolio is regulated as Class I devices and is listed in the FDA's 510k and UDI registries. The company is based in the US.
Catalogue
- GUDID
Bowhead ERA Wheelchairs Ref K243111
510(k) 510(k)
FDA establishments
- Bowhead Design Corp Calgary Alberta · CA FEI 3031658417
Frequently asked questions
How many devices does Bowhead Design Corp. have in the registry?
The registry currently lists 2 devices for Bowhead Design Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bowhead Design Corp.'s devices?
Among its 2 most recently registered devices, Bowhead Design Corp. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Bowhead Design Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bowhead Design Corp.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bowhead Design Corp. in the registry?
The most recently registered devices listed for Bowhead Design Corp. include Bowhead Era and Bowhead ERA Wheelchairs.
Which FDA establishments are linked to Bowhead Design Corp.?
1 FDA establishment is linked to Bowhead Design Corp. in the registry; they are listed on the company page.