Wrapped IN Comfort
Country not established
- Devices
- 2
What Wrapped IN Comfort makes
Wrapped In Comfort manufactures medical textiles designed to enhance patient comfort and safety, including an Incubator Cape for neonatal or pediatric care and a Light Drape for use in clinical settings to reduce glare and improve visibility during procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via 510(k) clearance. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Incubator Cape Ref K040794
Regimes: 510(k) Registry: 510(k)Light Drape Ref K043234
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Wrapped IN Comfort have in the registry?
The registry currently lists 2 devices for Wrapped IN Comfort. Devices recorded under merged duplicate company entries are counted once.
Which registries list Wrapped IN Comfort's devices?
Among its 2 most recently registered devices, Wrapped IN Comfort has devices listed in FDA 510(k) (2 devices).
What risk classes do Wrapped IN Comfort's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Wrapped IN Comfort's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Wrapped IN Comfort in the registry?
The most recently registered devices listed for Wrapped IN Comfort include INCUBATOR CAPE and LIGHT DRAPE.