Aid, Cardiopulmonary Resuscitation

What Is This Device?

CPR Aid device WITH feedback (visual, audio or both) on one or more CPR parameters (e.g., rate, depth, ventilation ratio, etc.), and contains software. Provides real-time feedback on CPR performance. Feedback can be audio, visual or both.

Device contains software

What Is FDA Product Code LIX?

Aid, Cardiopulmonary Resuscitation is FDA product code LIX, Class 2, 21 CFR 870.5210.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Do the Recalls Say?

The FDA has recorded 2 recalls under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.