510(k) Report

Devices descending from K150494

3 later devices reach Proteus Digital Health Feedback Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+1K183052ID-Cap SystemEtectrx, Inc.20190—
+2K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—