510(k) Report

Devices descending from K964208

5 later devices reach MD-1A Galvanic Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133033Hidrex PSP1000Hidrex GmbH201543
+2K241267Hidroxa SE30Hidroxa Medical AB20240—
+2K192749DermadryDermadry Laboratories, Inc.20201—
+2K191436SaalioSaalmann Medical GmbH & Co. KG20190—
+3K242041STOPWET iontophoresis apparatus (SW01)Taiwan Medical Electronics Co., Ltd.20250—