510(k) Report

Devices descending from K040966

86 later devices reach Modification to Carematix Wellness System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+1K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+1K113446Vignet Telehealth ManagerVignet, Inc.20128—
+1K100508Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc.20102—
+1K092635Alcatel-Lucent Teleheath ManagerAlcatel-Lucent Canada, Inc.20099—
+1K091021Modification to Medicompass ConnectImetrikus, Inc.20090—
+1K080091Modification to:Health Buddy ApplianceHealth Hero Network, Inc.20081—
+1K073038Carematix Wellness System, Model CWS-5000.1-BCarematix, Inc.20086—
+1K070543Modification to Health Buddy ApplianceHealth Hero Network, Inc.20072—
+1K063612Modification to Health Buddy ApplianceHealth Hero Network, Inc.200630—
+1K060843Modification to Health Buddy ApplianceHealth Hero Network, Inc.200639—
+1K052608Telephone Based BL Healthcare Remote Care Management System (RCMS)Bl Healthcare, Inc.20065—
+1K051470Remote Care Management Systems (RCMS)Bl Healthcare, Inc.200521—
+1K050929The Hermes SystemPalaistra Systems, Inc.200545—
+1K050567Health Buddy ApplianceHealth Hero Network, Inc.200540—
+1K042273Modification to Health Buddy with Device ConnectivityHealth Hero Network, Inc.200445—
+2K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+2K132930Myhealthpoint Telehealth ManagerEntra Health Systems20140—
+2K130971Optum Telehealth ApplicationOptumhealth Care Solutions, Inc.20131—
+2K130821Intel-GE Care Innovations Connect RCMIntel-Ge Care Innovations, LLC20130—
+2K122458Verizon Wireless Remote Health Management SystemCello Partnership D/B/A Verizon Wireless20132—
+2K123671Wellaho Personalized Outpatient Management SystemSanitas, Inc.20132—
+2K103796Telemedcare Health MonitorTelemedcare Pty, Ltd.20111—
+2K093895Ally Platform SystemContinuity Health Solutions20100—
+2K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+2K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc.20104—
+2K091220Healthanywhere SystemHealthanywhere, an Igeacare System Company20092—
+2K091430Care Pal, Model CPW-10XDigio2 International Co., Ltd.20090—
+2K090801Electronic House CallExpress MD Solutions, LLC20093—
+2K083046Fora Telehealth SystemTaidoc Technology Corporation20090—
+2K080798Intel Health Guide, Model: PHS6000Intel Corp.200825—
+2K073710Intouch Remote Presence Robotic System, Model RP-7Intouch Technologies20082—
+2K071564Motiva Monitor Device Connectivity, Model# 453564036921Philips Medical Systems20075—
+2K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc.200720—
+2K063484Patient Data Handler & Devices (PDH&D)Intermed Advisors, Inc.20064—
+2K062662Telemedicine System Model VMS-01Medic4all (Israel), Ltd.20062—
+2K062127MEDIC4ALL Telemedicine System, Model VMS-01 (Nibp)Medic4all (Israel), Ltd.20062—
+2K062215Confidant 2.0Confidant, Inc.200635—
+2K062304DLM112 Daylink MonitorRtx Healthcare A/S20068—
+2K061502MEDIC4ALL Telemedicine System VMS-01Medic4all (Israel), Ltd.20062—
+3K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+3K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—
+3K171406Optum TeleHealth ApplicationUnited Health Group, Inc.20170—
+3K132173Family HealthwareSanitas, Inc.20140—
+3K134004Verizon Wireless Converged Health Management DeviceCellco Partnership D/B/A Verizon Wireless20140—
+3K131739Nxstage Connected Health SystemNxstage Medical, Inc.20131—
+3K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+3K122333Mobilecare MonitorAframe Digital, Inc.20120—
+3K120895Remote Presence SystemIntouch Health, Inc.20121—
+3K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—
+3K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+3K111922Vocare Myhealth TabletVocare, Inc.20110—
+3K111932Iglucose SystemPositiveid Corporation20112—
+3K102063Health-E-Connect SystemAlr Technologies20111—
+3K110334Waldo Patient MonitorWaldo Health20111—
+3K103276Intel Health GuideIntel Corporation Digital Health Group201110—
+3K101178Modification to Intel Health Guide PHS6000Intel Corp.201011—
+3K091579Foresee HomeNotal Vision, Ltd.20094—
+3K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+3K083221Aidera DiasendAidera AB20093—
+3K083115Modification to Intel Health Guide, Model PHS6000Intel Corp.200812—
+3K072698Confidant 2.5Confidant, Inc.200734—
+3K071953RTX3370Rtx Healthcare A/S20073—
+4K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+4K163664Health-e-Connect System with IDAAlr Technologies20170—
+4K133997LG SmarthealthLg Electronics20140—
+4K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+4K132148S HealthSamsung Electronics Co., Ltd.20130—
+4K130290Modification to Intel-GE Care Iinovations GuideIntel-Ge Care Innovations, LLC20131—
+4K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+4K123229Remote Presence System, Model RP-VitaIntouch Health, Inc.20120—
+4K122285Tablet CommanderCardiocom, LLC20125—
+4K122095Icp TriagemanagerEmergo Europe Consulting BV20120—
+4K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+4K101806Aidera Diasend SystemAidera AB20102—
+4K090886RTX 3371Tunstall Healthcare20092—
+4K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+4K083331Confidant, Model 2.6Confidant, Inc.20092—
+5K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+5K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+5K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+5K132618Onetouch RevealLifescan, Inc.20130—
+5K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+5K103643Ascot Home Medical Monitoring System (HMMS)Ascot Technologies, Inc.20110—
+6K180895AlleyeOculocare Medical AG20181—
+7K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—