Roi Factory Direct Frame Co.
Country not established
- Devices
- 1
What Roi Factory Direct Frame Co. makes
Roi Factory Direct Frame Co. manufactures eyeglass frames designed for general use, including standard and fashion-oriented styles. These products are intended for optical correction and cosmetic enhancement without requiring prescription integration.
The company’s eyeglass frames are classified as Class I medical devices under FDA regulations, with submissions supported by 510(k) clearance. The products are listed in the FDA’s 510(k) database and comply with U.S. device classification standards.
Catalogue
Eyeglass Frame Ref K926157
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Roi Factory Direct Frame Co. have in the registry?
The registry currently lists 1 device for Roi Factory Direct Frame Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Roi Factory Direct Frame Co.'s devices?
Among its 1 most recently registered device, Roi Factory Direct Frame Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Roi Factory Direct Frame Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Roi Factory Direct Frame Co.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Roi Factory Direct Frame Co. in the registry?
The most recently registered devices listed for Roi Factory Direct Frame Co. include EYEGLASS FRAME.