Araluen, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Araluen, Inc. makes
Araluen, Inc. manufactures equine safety and handling equipment, including the Araluen Carrier—a transport device for horses—and the Araluen Sky Grab Bridle and Head Shield, designed to secure and control horse movement during transport or training.
These products are classified as Class I medical devices in the U.S. and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
The Araluen Carrier Ref K792566
Regimes: 510(k) Registry: 510(k)Araluen Sky Grab Bridle Ref K810922
Regimes: 510(k) Registry: 510(k)Araluen Head Shield Ref K810868
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Araluen, Inc. have in the registry?
The registry currently lists 3 devices for Araluen, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Araluen, Inc.'s devices?
Among its 3 most recently registered devices, Araluen, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Araluen, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Araluen, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Araluen, Inc. in the registry?
The most recently registered devices listed for Araluen, Inc. include THE ARALUEN CARRIER, ARALUEN SKY GRAB BRIDLE and ARALUEN HEAD SHIELD.