Bath, Hydro-Massage

How Is ILJ Classified?

Bath, Hydro-Massage is FDA product code ILJ, Class 2, 21 CFR 890.5100.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 10 recalls under this product code since 2025. None was by a company in China. The root cause the FDA records most often is Error in labeling (10).

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