510(k) Report

Devices descending from K032833

14 later devices reach Myosystem with Customizing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123795Axon-Bus Prosthetic SystemOtto Bock Austria201413—
+2K240884Glide (91000-GL-X)Infinite Biomedical Technologies, LLC20241—
+2K220002Dexus Prosthetics System (Model: MSL1, MSR1)Zhejiang Qiangnao Technology Co.,Ltd20223—
+2K182757Espire Elbow Pro, Espire Elbow HybridCollege Park Industries, Inc.20180—
+2K173571Element System with IBT ElectrodesInfinite Biomedical Technologies, LLC20180—
+2K162891Complete Control SystemCoapt, LLC20177—
+3K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd20260—
+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—
+3K191083COMPLETE CONTROL System Gen2Coapt, LLC20193—
+3K182112Sense System with IBT ElectrodesInfinite Biomedical Technologies, LLC20182—
+4K260453Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)Bionit Labs Srl20260—
+4K223738Alpha Control Liner System (ACLS)Coapt20232—
+4K191179Myo PlusOtto Bock Healthcare Products GmbH20191—