510(k) Report

Devices descending from K991561

5 later devices reach Roadrunner, Pep Therapy Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233855AllPEPEnchant Tek Co., Ltd.20240—
+1K160636iPEP System and vPEPD R Burton Healthcare, LLC20160—
+1K140772Aerosure MedicActegy, Ltd.20141—
+1K133057Vibralung Acoustical PercussorWestmed, Inc.20140—
+2K203378PulsehalerRespinova, Ltd.20210—