Ems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Ems, Inc. makes
Ems, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) devices, including the TENS-IT and FITTRONIC II systems, designed for pain management. The company also produces the CMT-1000, a device for neuromuscular electrical stimulation (NMES). These products are intended for therapeutic applications in clinical and home settings.
The company’s devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) clearance registry. Ems, Inc. is based in the United States.
Catalogue
Tens-It, Fittronic Ii, (More Later) Ref K946018
Regimes: 510(k) Registry: 510(k)Cmt-1000 Ref K942428
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ems, Inc. have in the registry?
The registry currently lists 2 devices for Ems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ems, Inc.'s devices?
Among its 2 most recently registered devices, Ems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Ems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ems, Inc. in the registry?
The most recently registered devices listed for Ems, Inc. include TENS-IT, FITTRONIC II, (MORE LATER) and CMT-1000.