Alpha Unlimited, Inc.
United StatesFDA applicant, unverified
- Devices
- 10
What Alpha Unlimited, Inc. makes
Alpha Unlimited, Inc. manufactures utility carts and patient support devices, including the ALPHA TRI-KART, ALPHA MALLARD, and ALPHA PUSH KART for medical transport, as well as the MAC-MULTI-ADJUSTABLE CHAIR for patient positioning. Their portfolio also includes shopping carts like the ALPHA SHOPPER and ALPHA PLUS 1, alongside disposable umbilical cord clamps such as the #556 DISPOSABLE UMBILICAL CORD CLAMP. Additional products include the ALPHA CONDOR and ALPHA SUPER KART for medical logistics.
The company’s devices are regulated under FDA’s Class I and Class II classifications, with several authorised via the 510(k) pathway. These products are listed in the FDA’s 510(k) database, and the manufacturer operates from the United States.
Catalogue
Alpha 4 X 4 Ref K841912
Regimes: 510(k) Registry: 510(k)Alpha Tri-Kart Ref K841919
Regimes: 510(k) Registry: 510(k)Alpha Mallard Ref K893248
Regimes: 510(k) Registry: 510(k)Alpha Push Kart Ref K841911
Regimes: 510(k) Registry: 510(k)Alpha Condor Ref K893429
Regimes: 510(k) Registry: 510(k)Mac-Multi-Adjustable Chair Ref K841920
Regimes: 510(k) Registry: 510(k)Alpha Shopper Ref K893428
Regimes: 510(k) Registry: 510(k)Alpha Plus 1 Ref K841921
Regimes: 510(k) Registry: 510(k)Alpha Super Kart Ref K853766
Regimes: 510(k) Registry: 510(k)#556 Disposable Umbilical Cord Clamp (2) Ref K894646
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Alpha Unlimited, Inc. have in the registry?
The registry currently lists 10 devices for Alpha Unlimited, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha Unlimited, Inc.'s devices?
Among its 10 most recently registered devices, Alpha Unlimited, Inc. has devices listed in FDA 510(k) (10 devices).
What risk classes do Alpha Unlimited, Inc.'s devices fall under?
Among its 10 most recently registered devices, the classes recorded for Alpha Unlimited, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Alpha Unlimited, Inc. in the registry?
The most recently registered devices listed for Alpha Unlimited, Inc. include ALPHA 4 X 4, ALPHA TRI-KART, ALPHA MALLARD and ALPHA PUSH KART.