Romaine, Inc.
Country not established
- Devices
- 1
What Romaine, Inc. makes
Romaine, Inc. manufactures the KOLD WRAP, a reusable cold therapy device designed for post-procedure or post-surgical pain management and swelling reduction.
The KOLD WRAP is classified as a Class I medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Kold Wrap Ref K801365
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Romaine, Inc. have in the registry?
The registry currently lists 1 device for Romaine, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Romaine, Inc.'s devices?
Among its 1 most recently registered device, Romaine, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Romaine, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Romaine, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Romaine, Inc. in the registry?
The most recently registered devices listed for Romaine, Inc. include KOLD WRAP.