510(k) Report

Devices descending from K003909

14 later devices reach Proact 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123647Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc.201312—
+1K052243Proact with Gel or Proact 1Proact, Inc.20060—
+2K172779AIROS 8 Sequential Compression DeviceAiros Medical, Inc.20182—
+2K172770AIROS 6 Sequential Compression DeviceAiros Medical, Inc.20183—
+2K143185entré Model PD08-UTactile Systems Technology, Inc.20154—
+3K254217AerloomEvolym, LLC20260—
+3K234155Nimbl (model PD08-N1)Tactile Medical20240—
+3K212287Dayspring LiteKoya Medical, Inc.20210—
+3K200564Aria SystemInova Labs20200—
+3K193069AIROS 6 Sequential Compression DeviceAiros Medical, Inc.20192—
+3K193068AIROS 8 Sequential Compression DeviceAiros Medical, Inc.20191—
+4K223193AIROS 8P Sequential Compression DeviceAiros Medical, Inc.20220—
+4K223195AIROS 6P Sequential Compression DeviceAiros Medical, Inc.20221—
+5K251086PnueAira (PNCU-01)Biotab, LLC20250—