510(k) Report

Devices descending from K201669

3 later devices reach SimpleSENSE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+1K212160SimpleSENSE PlatformNanowear, Inc.20211—
+2K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—