510(k) K191113

geko T-2 and geko T-3 Neuromuscular Stimulators by Firstkind Limited — Product Code IPF

K191113 is an FDA 510(k) premarket notification submitted by Firstkind Limited for the device "geko T-2 and geko T-3 Neuromuscular Stimulators". The FDA issued a decision of Substantially Equivalent on Sep 18, 2019. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Firstkind Limited has 10 other 510(k) clearances on record.