(182 days)
The TheraFlow Oxygen Conserving Device Regulator is intended for prescription use only, to be used in conjunction with a portable oxygen tank for adult patients prescribed supplemental oxygen therapy for use inside the home or outside in ambulatory applications on patients with mobility. It is not intended for life support applications.
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I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA 510(k) clearance letter for a device called "TheraFlow Single and Dual Lumen Regulation" (K131023).
This letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment methods.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and device performance based on the input text.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).