510(k) Report

Devices descending from K162891

7 later devices reach Complete Control System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191083COMPLETE CONTROL System Gen2Coapt, LLC20193—
+1K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC20182—
+2K223738Alpha Control Liner System (ACLS)Coapt20232—
+2K191179Myo PlusOtto Bock Healthcare Products GmbH20191—
+3K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…Otto Bock Healthcare Products GmbH20260—
+3K242326Wave Electrode (AE02-60); Wave Electrode (AE02-50)Bionit Labs Srl20251—
+4K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl20260—