3 ms·
Please note the small text on this page that says: "There is no guarantee this device will remove debris from the airway." http://www.dechoker.com/pages/dechok
by deltaecho1338 11y ago
Please note the small text on this page that says: "There is no guarantee this device will remove debris from the airway."
http://www.dechoker.com/pages/dechoker-usage-instructions http://www.dechoker.com/pages/dechoker-usage-instructions
It is a 510K-exempt Class I medical device, according to the FDA. So its manufacturer has registered with the FDA but there is no FDA approval of its claim of being able to dislodge objects from a patient's airway. Nor is any data provided to demonstrate that it is at all effective.
- userbinator 11y agoThere is no guarantee this device will remove debris from the airway. That's somewhat of a "duh!" but I guess it's there just for legal reasons.