Could the Korean intended-use wording place the supplied component in a medical-device accessory category?
Last reviewed: .
Could the Korean intended-use wording place the supplied component in a medical-device accessory category?
The company publishes no medical use for the filter and no accessory claim.
The label for the NanoFlashing™ Air Filter states: “It is not a medical device and is not intended to diagnose, treat, cure or prevent disease. It works alongside ventilation and cleaning, not in place of them.” The Terms of Use state: “Do not use Site Content to diagnose, treat, or make a patient-care or infection-control decision.” They also state: “A laboratory reduction in a virus, bacterium, fungus, particle, or other endpoint does not establish a clinical benefit, fewer infections, disease prevention or treatment, or improved health.” The Terms further state that the Medical devices chapter describes a Research Application, and that it does not describe a finished product currently available from C-POLAR for that use.
Source: NanoFlashing™ Air Filter label; C-POLAR — Terms of Use (https://cpolar.tech/terms/).
Reviewed on .
Sources
- NanoFlashing™ Air Filter label
- C-POLAR — Terms of Use