Oxygen Concentrator (J10A)

The Oxygen Concentrator (J10A) is a portable medical device that provides supplemental oxygen to adult patients requiring oxygen therapy. It separates nitrogen from room air using a molecular sieve and pressure swing adsorption to deliver 90-96% oxygen at flow rates of 1-10 L/min for use in homes or healthcare facilities. The device is not intended to sustain or support life.

The subject device operates on AC 100-120V, 60Hz power with maximum input of 550VA, delivering oxygen at 93±3% concentration and 40-80 kPa outlet pressure. It produces ≤60dB(A) noise at maximum flow, features Class II Type BF electrical classification, and includes alarms for low oxygen purity, pressure anomalies, power loss, sensor failure, and flow rate issues. The device has identical dimensions (620×370×345mm), operating principle, working mode, and safety features as the predicate device.

IEC 60601-1-2:2014+A1:2020 and IEC TR 60601-4-2:2016 (electromagnetic compatibility); IEC 60601-1:2020, IEC 60601-1-8:2012, IEC 60601-1-11:2020, and ISO 80601-2-69:2020 (electrical safety); ISO 18562-2 and ISO 18562-3 (biocompatibility); IEC 62366-1 and IEC 60601-6 (usability).

The subject device is substantially equivalent to predicate K240840 because it has identical intended use, indications, operating principles, performance specifications, safety features, and dimensions. Both devices use the same pressure swing adsorption technology with molecular sieve filtering, deliver identical oxygen concentrations and flow rates, and comply with the same regulatory standards. The only differences are the manufacturer name and model designation, with no changes to the device's safety or effectiveness.