Component Equipment Mfg., Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Component Equipment Mfg., Inc. makes
Component Equipment Mfg., Inc. manufactures passive foot and ankle exercisers, such as the PODOFLEX EXERCISER, and traction devices like the ULTRA TRACTION. These products are designed for physical rehabilitation and mobility support, targeting lower limb movement and therapeutic traction applications.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with submissions recorded in the 510(k) clearance pathway. Products are listed in the U.S. regulatory system, adhering to domestic medical device compliance requirements.
Catalogue
Podoflex Exerciser-Passive-Foot/Ankle Ref K901796
Regimes: 510(k) Registry: 510(k)Ultra Traction Ref K881603
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Component Equipment Mfg., Inc. have in the registry?
The registry currently lists 2 devices for Component Equipment Mfg., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Component Equipment Mfg., Inc.'s devices?
Among its 2 most recently registered devices, Component Equipment Mfg., Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Component Equipment Mfg., Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Component Equipment Mfg., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Component Equipment Mfg., Inc. in the registry?
The most recently registered devices listed for Component Equipment Mfg., Inc. include PODOFLEX EXERCISER-PASSIVE-FOOT/ANKLE and ULTRA TRACTION.