Mv Life, LLC · Class II · Cleared Apr 23, 2026
| K-number | K252407 |
| Device name | OxyGo Portable Oxygen Concentrator (1400-7000) |
| Applicant | Mv Life, LLC |
| Product code | CAW |
| Device class | Class II |
| Decision date | Apr 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 868.5440 |
The OxyGo Portable Oxygen Concentrator is a Class II portable oxygen generator that delivers supplemental oxygen to patients requiring respiratory therapy on a prescription basis. It can be used in home, institutional, vehicle, and transport settings via a nasal cannula, and is not intended to be life-sustaining or life-supporting.
The device uses molecular sieve/pressure swing adsorption technology to concentrate oxygen from ambient air, delivering it via pulse-dose mode during patient inhalation. It offers multiple power options (AC, DC, and rechargeable battery), produces 93% oxygen purity (±3%), has a maximum output pressure of <20.31 PSI, and includes an LCD display, LED indicators, auditory alarms, and user-replaceable sieve beds and filters.
Electrical safety and EMC per IEC 60601-1:2012, IEC 60601-1-2:2012, IEC 60601-1-6:2020, IEC 60601-1-8:2012, IEC 60601-1-11:2015, ISO 80601-2-67:2020, and ISO 80601-2-69:2020; biocompatibility per ISO 18562-2:2017 and ISO 18562-3:2017; software per IEC62304:2015; and usability per IEC 62366-1 and IEC 60601-6.
The OxyGo is substantially equivalent to the Inogen Rove 6 (K230052) predicate device because both share identical indications for use, the same principle of operation (pulse-dose molecular sieve oxygen concentration), same intended users, and comparable performance specifications across oxygen purity, output pressure, and delivery mode, with any dimensional or accessory differences determined not to impact safety or effectiveness.
View the full FDA submission: accessdata.fda.gov