Portable Oxygen Concentrator (JM-P50A)

The Jumao JM-P50A is a portable oxygen concentrator that provides supplemental oxygen to adult patients (ages 22 and older) requiring respiratory therapy on a prescription basis. It uses molecular sieve technology to concentrate oxygen from ambient air and delivers it via pulse-dose during inhalation, and can be used in homes or professional healthcare facilities.

The JM-P50A uses the same molecular sieve/pressure swing adsorption technology and pulse-dose delivery as the predicate Inogen Rove 6. Key differences include: no external battery charger (predicate has optional EBC); no mobile app or Bluetooth (predicate has Inogen Connect app); slightly higher acoustic noise (61 dBA vs 54 dBA at maximum); slightly larger dimensions but lighter weight; 8-cell lithium battery only (predicate offers 8 or 16-cell options); sieve beds require trained technician replacement (predicate allows user replacement).

ANSI AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2:2020, IEC 60601-1-8:2020, IEC 60601-1-11:2020, ISO 80601-2-69:2020, ISO 80601-2-67:2020, IEC 62133-2:2017, ISO 18562-1:2024, ISO 18562-2:2017, ISO 18562-3:2017, IEC 62304:2006, and ISO 10993-17:2023.

The JM-P50A and predicate device share identical intended use (prescription oxygen therapy for adults at home or healthcare facilities), same fundamental technology (molecular sieve pulse-dose delivery), and equivalent performance specifications (oxygen purity 90%±3/+6%, outlet pressure <199 kPa, inspiratory trigger sensitivity <0.12 cmH2O, same flow settings). Differences in accessories, user interface details, battery options, and acoustic noise do not raise different safety or effectiveness questions because the device was tested to applicable standards and all performance metrics meet required specifications. The device's limited intended environment (home and healthcare facilities only) further supports equivalence since the absence of features like DC power cable, external charger, and mobile connectivity does not affect safety or performance within its intended scope.