Hello all,
We obtained a 510(k) for a class II medical device used in emergency rooms. Our customers would like a wall cabinet to store the devices in, so that they easily know where they are located. This is literally a box of sheet metal with a hinged door and the product logo on it. In no way is it needed for the use of the device. I am not sure if this is considered a device by the FDA and would welcome your feedback. I could not find any class I or II product codes that apply.
Per the FDA Medical Device Accessories guidance (can't link), you could argue that by storing the class II device, then the wall cabinet supports (literally) the class II parent device and therefore the wall cabinet is a device itself. If that is the case, then the cabinet would also be class II unless we follow the classification process described in the guidance as far as I understand it.
I appreciate any insight you might have for me.
We obtained a 510(k) for a class II medical device used in emergency rooms. Our customers would like a wall cabinet to store the devices in, so that they easily know where they are located. This is literally a box of sheet metal with a hinged door and the product logo on it. In no way is it needed for the use of the device. I am not sure if this is considered a device by the FDA and would welcome your feedback. I could not find any class I or II product codes that apply.
Per the FDA Medical Device Accessories guidance (can't link), you could argue that by storing the class II device, then the wall cabinet supports (literally) the class II parent device and therefore the wall cabinet is a device itself. If that is the case, then the cabinet would also be class II unless we follow the classification process described in the guidance as far as I understand it.
I appreciate any insight you might have for me.