Dan Med, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Dan Med, Inc. makes
Dan Med, Inc. manufactures electrical muscle stimulation (EMS) devices, including systems like the AM800 AutoMove and NEUROMOVE NM900, designed for neuromuscular re-education and rehabilitation. Their portfolio also includes continuous EMS units such as the ELPHA 2000 Conti, as well as EMG-triggered stimulation devices like the TRUWAVE and IF8000 for targeted muscle activation. Additional offerings include the EMS 3000, a standalone EMS unit for therapeutic applications.
The company’s devices are classified as Class II under FDA regulations and are authorised through the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, ensuring compliance with US medical device standards. Dan Med, Inc. is based in the United States.
Catalogue
Truwave Ref K013210
Regimes: 510(k) Registry: 510(k)IF8000 Ref K991241
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Ems 3000 Ref K010745
Regimes: 510(k) Registry: 510(k)Elpha 2000 Conti Ref K964738
Regimes: 510(k) Registry: 510(k)Neuromove NM900 Ref K012885
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dan Med, Inc. have in the registry?
The registry currently lists 6 devices for Dan Med, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dan Med, Inc.'s devices?
Among its 6 most recently registered devices, Dan Med, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Dan Med, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Dan Med, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dan Med, Inc. in the registry?
The most recently registered devices listed for Dan Med, Inc. include TRUWAVE, IF8000, AM800 AUTOMOVE EMG TRIGGERED ELECTRICAL MUSCLE STIMULATION and EMS 3000.