510(k) Report

Devices descending from K182112

2 later devices reach Sense System with IBT Electrodes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191179Myo PlusOtto Bock Healthcare Products GmbH20191—
+2K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial…Otto Bock Healthcare Products GmbH20260—