510(k) Report

Devices descending from K231569

1 later device reach ManaFlexx 2 (model: MF002-RX, MF002-OTC) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243613Patch-TEA (Model TRI-21)Transtimulation Research, Inc.20250—