Urometrics, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Urometrics, Inc. makes
Urometrics, Inc. manufactures diagnostic and therapeutic medical devices for male and female sexual health, including an ultrasonic system for diagnosing male impotence, a clitoral therapy device, and a system for treating sexual dysfunction.
The company’s portfolio includes Class II and Class U devices, all of which are subject to FDA 510(k) clearance requirements. These devices are listed under U.S. regulatory frameworks, and the manufacturer is based in the United States.
Catalogue
- 510(k) 510(k)
Eros-Clitoral Therapy Device (Ctd) Ref DEN000006
De Novo 510(k)Neva System Ref K980627
510(k) 510(k)
Frequently asked questions
How many devices does Urometrics, Inc. have in the registry?
The registry currently lists 3 devices for Urometrics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Urometrics, Inc.'s devices?
Among its 3 most recently registered devices, Urometrics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Urometrics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Urometrics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Urometrics, Inc. in the registry?
The most recently registered devices listed for Urometrics, Inc. include KNOLL/MIDUS (MALE IMPOTENCE DIAGNOSTIC ULTRASONIC SYSTEM), EROS-CLITORAL THERAPY DEVICE (CTD) and NEVA SYSTEM.