510(k) Report

Devices descending from K191441

2 later devices reach Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211460Air Relax Plus Model AR-3.0Diode Art Engineering Doing Business AS Air Relax20211—
+2K212491Air Relax Pro Model AR-4.0Diode Art Engineering Doing Business AS Air Relax20210—