Diathermy, Shortwave, for Use in Applying Therapeutic Deep Heat

How Is IMJ Classified?

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat is FDA product code IMJ, Class 2, 21 CFR 890.5290.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 1 clearance under this code; the FDA took 262 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2015. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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