510(k) K250625

Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) by Nanjing Yinuoji Medical Technology Co., Ltd. — Product Code CAW

K250625 is an FDA 510(k) premarket notification submitted by Nanjing Yinuoji Medical Technology Co., Ltd. for the device "Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite))". The FDA issued a decision of Substantially Equivalent on August 27, 2025. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440.