Ultrasonic Diathermy for Use in Applying Therapeutic Deep Heat

What Is FDA Product Code IMI?

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat is FDA product code IMI, Class 2, 21 CFR 890.5300.

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

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 377 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2005. None was by a company in China. The root cause the FDA records most often is Component design/selection (2).

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