Allan Rehnstrom AB
SE Last updated 22 Oct 2026
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Alreco 40400 Ref K951926
What Allan Rehnstrom AB makes
Allan Rehnstrom AB manufactures the ALRECO 40400, a medical device designed for respiratory support, specifically as a portable oxygen concentrator.
The device falls under FDA Class II regulation and is listed via the 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Allan Rehnstrom AB manufacture?
Allan Rehnstrom AB specializes in respiratory support devices. Specifically, they produce the ALRECO 40400, which is designed as a portable oxygen concentrator. This device is intended to provide patients with a compact, mobile solution for delivering concentrated oxygen therapy.
Where is Allan Rehnstrom AB based?
Allan Rehnstrom AB is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as it operates within the jurisdiction of U.S. medical device regulations.
How are Allan Rehnstrom AB’s devices classified under U.S. regulations?
The ALRECO 40400, the primary device manufactured by Allan Rehnstrom AB, is classified as a Class II medical device under the FDA’s regulatory framework. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, which may include performance standards or post-market surveillance.
Which regulatory registries or databases list Allan Rehnstrom AB’s devices?
Allan Rehnstrom AB’s devices, including the ALRECO 40400, are listed in the FDA’s 510(k) database. This pathway is used for demonstrating substantial equivalence to a legally marketed predicate device, ensuring compliance with U.S. regulatory requirements before commercial distribution.
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