510(k) K232786

Stimulation System (PA series, PR series, S series and Q series) by Edan Instruments, Inc. — Product Code IPF

K232786 is an FDA 510(k) premarket notification submitted by Edan Instruments, Inc. for the device "Stimulation System (PA series, PR series, S series and Q series)". The FDA issued a decision of Substantially Equivalent on May 16, 2024. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Edan Instruments, Inc. has at least 10 other 510(k) clearances on record.