Oxygen Concentrator (ZY-10AB/115)

The Oxygen Concentrator (ZY-10AB/115) is a portable device that provides supplemental oxygen to patients requiring it by separating nitrogen from room air using a molecular sieve and pressure swing adsorption technology. It delivers 90-96% oxygen at flow rates of 1-10 L/min for use in home or healthcare facility settings, and is not intended to sustain or support life.

The device operates on AC 100-120V, 60Hz power with a maximum input of 550VA, delivers oxygen at 93±3% concentration with outlet pressure of 40-80 kPa, produces noise ≤60dB(A) at maximum flow rate, and uses synthetic zeolite sieve beds with analog/digital electronics and microprocessor control. It is classified as Class II Type BF electrical equipment and includes alarms for low oxygen purity, pressure extremes, power loss, oxygen sensor failure, low flow rate, and display circuit board failure.

IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-1-11:2015/AMD1:2020 (electric safety), ISO 80601-2-69:2014 (respiratory devices), IEC 80601-1-8:2020, ISO 18562-2:2017 and ISO 18562-3:2017 (biocompatibility of breathing gas pathways), IEC 62366-1 and IEC 60601-6 (usability).

The device is substantially equivalent to predicate K222920 because both use identical pressure swing adsorption technology with molecular sieves to deliver 93±3% oxygen in continuous mode for home/healthcare use with substantially similar intended patient populations. Although minor performance differences exist (oxygen flow 1-10 vs 0-10 L/min, outlet pressure 40-80 vs 20-60 kPa, different alarm configurations), all differences comply with ISO 80601-2-69 safety standards and do not affect safety or effectiveness. Both devices meet the same electromagnetic compatibility and electrical safety standards, use the same operating system approach, and have comparable biocompatibility requirements.