510(k) K061365

CHECKPOINT WITH ACCUSTIM TECHNOLOGY by Ndi Medical, LLC — Product Code ETN

K061365 is an FDA 510(k) premarket notification submitted by Ndi Medical, LLC for the device "CHECKPOINT WITH ACCUSTIM TECHNOLOGY". The FDA issued a decision of Substantially Equivalent on July 12, 2006. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Ndi Medical, LLC has at least 2 other 510(k) clearances on record.