Polar Wrap, LLC
Country not established
- Devices
- 1
What Polar Wrap, LLC makes
Polar Wrap, LLC manufactures health masks designed for respiratory protection and filtration, intended for use in clinical or public health settings.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Health Mask Ref K070467
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Polar Wrap, LLC have in the registry?
The registry currently lists 1 device for Polar Wrap, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polar Wrap, LLC's devices?
Among its 1 most recently registered device, Polar Wrap, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Polar Wrap, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Polar Wrap, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polar Wrap, LLC in the registry?
The most recently registered devices listed for Polar Wrap, LLC include HEALTH MASK.