Nite Train-R Enterprises, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Nite Train-R Enterprises, Inc. makes
Nite Train-R Enterprises, Inc. manufactures sleep-related medical devices, including the NITE TRAIN'R—a device designed to assist with sleep training—and the BED ALERT, which appears to monitor or signal bed occupancy or movement.
These products fall under FDA Class II regulation and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Nite Train'r Ref K780660
Regimes: 510(k) Registry: 510(k)Bed Alert Ref K872522
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Nite Train-R Enterprises, Inc. have in the registry?
The registry currently lists 2 devices for Nite Train-R Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nite Train-R Enterprises, Inc.'s devices?
Among its 2 most recently registered devices, Nite Train-R Enterprises, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Nite Train-R Enterprises, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Nite Train-R Enterprises, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Nite Train-R Enterprises, Inc. in the registry?
The most recently registered devices listed for Nite Train-R Enterprises, Inc. include NITE TRAIN'R and BED ALERT.