Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))

The Portable Oxygen Concentrator (models W-R1(MAX), W-R1, W-R2, W-R2(Lite)) is a Class II device that provides high-concentration supplemental oxygen (87%-95.5%) to adult patients requiring respiratory therapy on a prescription basis. It uses Pressure Swing Adsorption (PSA) technology with pulse-dose oxygen delivery and can be used at home, in institutions, vehicles, aircraft, and other transport modalities; it is not intended for life support.

The device uses the same fundamental molecular sieve/PSA technology and pulse-dose delivery mechanism as the predicate (Inogen Rove 6). Key differences include: USB Type-C power connector (vs. barrel jack in predicate); no external battery charger or Bluetooth/mobile app features; no DC power cable currently available; fixed rather than adjustable alarm volume; higher maximum pulse flow (1470 ml/min vs. 1260 ml/min); and slightly different oxygen purity specification (90% ±3%/+5.5% vs. 90% ±3%/+6%).

ISO 80601-2-69:2020 and ISO 80601-2-67:2020 (oxygen concentrator safety and performance); IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020, IEC 60601-1-6:2010, IEC 60601-1-8:2006, IEC 60601-1-11:2015 (electrical safety and medical device standards); ISO 18562-2:2024 and ISO 18562-3:2024 (biocompatibility); IEC 62133-2:2017 (lithium battery safety); and internal bench testing for oxygen purity, pulse volume, trigger sensitivity, temperature/altitude/pressure limits, alarm functions, and battery life.

The subject device shares the same intended use, product code (CAW), classification (Class II), and fundamental operating principle (PSA with pulse-dose delivery) as the Inogen Rove 6 predicate. Although the subject device has a higher maximum pulse flow (1470 vs. 1260 ml/min), the applicant demonstrates this remains within FDA-cleared parameters by citing the GCE Zen-O (K162433), which has even higher pulse flow (2000 ml/min). Performance differences (e.g., USB vs. barrel jack connector, absence of optional mobile app, fixed vs. adjustable alarm) are characterized as non-functional design choices that do not raise new safety or effectiveness questions. The device underwent the same battery of performance, biocompatibility, and electrical safety testing per relevant ISO/IEC standards, with all tests meeting required standards.