Elite Medical, LLC
United Statesfrom the FDA registration address FDA establishment FEI 3009256700
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
What Elite Medical, LLC makes
Elite Medical, LLC manufactures the EM-9000, a medical device designed for [specific application not provided in data]. The product falls under Class II regulatory classification, indicating moderate risk and requiring compliance with performance standards.
The EM-9000 is regulated under the FDA’s 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. The company is based in the United States.
Catalogue
Em-9000 Ref K101482
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3009256700
- Address
- 8415 Wolf Lake Dr, Bartlett, TN, 38133
Frequently asked questions
How many devices does Elite Medical, LLC have in the registry?
The registry currently lists 1 device for Elite Medical, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Elite Medical, LLC's devices?
Among its 1 most recently registered device, Elite Medical, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Elite Medical, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Elite Medical, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Elite Medical, LLC in the registry?
The most recently registered devices listed for Elite Medical, LLC include EM-9000.