510(k) K202337

Pulsed electromagnetic field wrap by Hi-Dow International, Inc. — Product Code ILX

K202337 is an FDA 510(k) premarket notification submitted by Hi-Dow International, Inc. for the device "Pulsed electromagnetic field wrap". The FDA issued a decision of Substantially Equivalent on December 15, 2020. The device falls under product code ILX (Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Hi-Dow International, Inc. has at least 5 other 510(k) clearances on record.