Shenzhen Homed Medical Device Co., Ltd. · Class II · Cleared Dec 22, 2025
| K-number | K252616 |
| Device name | Portable oxygen concentrator (JLO-190P) |
| Applicant | Shenzhen Homed Medical Device Co., Ltd. |
| Product code | CAW |
| Device class | Class II |
| Decision date | Dec 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 868.5440 |
The JLO-190P is a portable oxygen concentrator that uses molecular sieve pressure swing adsorption to concentrate oxygen from ambient air for patients requiring supplemental oxygen. It operates in pulse-dose mode, detecting the patient's breathing and delivering oxygen during inhalation. It is intended for home, institutional, and transport use as a supplemental oxygen device, not for life support.
The device employs pressure swing adsorption with molecular sieve technology, identical to the predicate Inogen Rove 6. It produces 93%±3% oxygen concentration, uses lithium-ion batteries, operates at output pressures ≤26.1 PSI, and includes a 2.8-inch color display with breath detection LEDs and alarm indicators compliant with ISO 60601-1-8.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, ISO 80601-2-67, ISO 80601-2-69, IEC 62304, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 18562-1, ISO 18562-2, and ISO 18562-3.
The JLO-190P is substantially equivalent to the Inogen Rove 6 predicate (K230052) because both devices share identical intended use, patient population, settings, classification, and core pressure swing adsorption technology with molecular sieve. Design differences do not raise new safety or effectiveness issues, and non-clinical testing demonstrates compliance with applicable consensus standards.
View the full FDA submission: accessdata.fda.gov