510(k) K251083

Compact II by Enraf-Nonius, B.V. — Product Code IPF

K251083 is an FDA 510(k) premarket notification submitted by Enraf-Nonius, B.V. for the device "Compact II". The FDA issued a decision of Substantially Equivalent on September 12, 2025. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Enraf-Nonius, B.V. has at least 4 other 510(k) clearances on record.