FreeStyle Comfort (AS200 / FreeStyle Comfort)

The FreeStyle Comfort is a portable, lightweight (5-6 lbs) oxygen concentrator that delivers concentrated oxygen (90% ±5.5%/-3%) to patients requiring supplemental oxygen therapy on a prescription basis. It operates via pulse-dose delivery (fixed-minute or autoSAT modes) and can be used in homes, institutions, and during transport, including on commercial aircraft. The device is not intended for life support.

Both the subject device and predicate (Inogen Rove 4) use Pressure Swing Adsorption (PSA) technology with dual molecular sieve beds to separate oxygen from nitrogen. Both deliver oxygen as a bolus at the start of inhalation, sense breath-triggered demand, and employ lithium-ion batteries with AC/DC power options. The subject device offers five fixed flow settings plus autoSAT; the predicate offers four fixed settings. Both achieve identical 90% oxygen concentration and deliver via standard nasal cannula.

ISO 80601-2-69 (oxygen concentrator basic safety and performance), ISO 80601-2-67 (oxygen-conserving equipment), IEC 60601-1 series (medical electrical equipment safety), IEC 62366-1 (usability), ISO 18562-2 and -3 (biocompatibility—particulate matter and volatile organic compounds), and sound testing per ISO 3744.

The subject and predicate devices employ identical PSA oxygen separation technology, produce the same oxygen concentration (90%+5.5%/-3%), and deliver oxygen via identical demand-based pulse dosing to the same patient population in identical use environments (home, institution, transport). The differences—larger battery capacity (8/16-cell vs. 4/8-cell), one additional flow setting, and autoSAT capability in the subject device—are enhancements that do not introduce new safety or effectiveness concerns because the fundamental operating principle, oxygen output specification, user interface paradigm, and power/component architecture remain substantially unchanged.