Lumex, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Lumex, Inc. makes
Lumex, Inc. manufactures mobility and patient support devices, including manual mechanical wheelchairs (e.g., Series 1000, 3000, 4000, 5000, and Tilt-in-Space models), MRI-compatible wheelchairs, shower chairs, bed/stretcher systems, linen and utility carts, and air-fluidized low-air-loss systems (e.g., Akrotech 4000T). Their portfolio also includes ergonomic patient transfer aids like the 577ES (Ergosense) and specialized air mattresses such as the Lumex Air.
The company’s devices are classified under FDA regulations as Class I or Class II, with submissions supported by 510(k) clearances. Products are listed in the U.S. under the FDA’s 510(k) pathway, and the manufacturer operates from the United States.
Catalogue
Mechanical Wheelchair 890.3850 Ref K945175
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Shower Chairs;bed/Stretcher;linen & Utility Cart Ref K895740
Regimes: 510(k) Registry: 510(k)577ES (Ergosense) Ref K945257
Regimes: 510(k) Registry: 510(k)Akrotech 4000 Ref K923977
Regimes: 510(k) Registry: 510(k)Altadyne Ref K953675
Regimes: 510(k) Registry: 510(k)Lumex Air Ref K963674
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lumex, Inc. have in the registry?
The registry currently lists 8 devices for Lumex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lumex, Inc.'s devices?
Among its 8 most recently registered devices, Lumex, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Lumex, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Lumex, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lumex, Inc. in the registry?
The most recently registered devices listed for Lumex, Inc. include MECHANICAL WHEELCHAIR 890.3850, LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPACE, 6000, MRI), SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART and 577ES (ERGOSENSE).