Katalyst, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Katalyst, Inc. makes
Katalyst, Inc. manufactures medical training systems and muscle stimulation devices, including the Katalyst Training System and the Katalyst Mark 1 Muscle Stimulation System (Model 2 and standard). These products are designed for therapeutic and rehabilitative applications, focusing on neuromuscular stimulation and patient training.
The company’s portfolio is classified under FDA Class II devices and is subject to 510(k) clearance in the United States. The devices are listed in the FDA’s regulatory database, adhering to U.S. medical device regulations.
Catalogue
Katalyst Training System Ref K190966
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Katalyst Mark 1 Muscle Stimulation System Ref K171035
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Katalyst, Inc. have in the registry?
The registry currently lists 3 devices for Katalyst, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Katalyst, Inc.'s devices?
Among its 3 most recently registered devices, Katalyst, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Katalyst, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Katalyst, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Katalyst, Inc. in the registry?
The most recently registered devices listed for Katalyst, Inc. include Katalyst Training System, Katalyst Mark 1 Muscle Stimulation System Model 2 and Katalyst Mark 1 Muscle Stimulation System.