(189 days)
The TRI-BALL is an incentive spirometer, in other words, a respiratory execiser, The THI-BALL Is an Incentive spiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.
The TRI-BALL is an incentive spirometer, in other words, a respiratory execiser, The THI-BALL Is an Incentive spiratory flow rate and that provides an incentive to the patient to improve his or her ventilation.
This is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving a device meets them. It primarily states that the TRI-BALL device is substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information based on the provided text.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).