510(k) Report

Devices descending from K061328

24 later devices reach Think Positive Diabetes Management System (T+Diabetes System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093789Intouch DiabetesSymcare Personalized Health Solutions, Inc.20100—
+1K091296Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09Polymap Wireless20090—
+1K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc.20091—
+1K062377Medapps Remote Patient Monitoring, Model MA 100Medapps, Inc.200720—
+2K130676Ambio Remote Health Monitoring SystemArrayent Health, LLC D/B/A Ambio Health20131—
+2K112559Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.20114—
+2K111932Iglucose SystemPositiveid Corporation20112—
+2K093379TCX-I-DV Remote Care Management SystemBl Healthcare, Inc.20104—
+2K083862Medapps 2.0 Remote Patient Monitoring SystemMedapps, Inc.200912—
+3K133252Healthinterlink BeaconHealthinterlink, LLC20143—
+3K132803Medapps 2.0 Remote Patient Monitoring System, Healthpal, Healthcom, Mobile LinkMedapps Inc., Dba Alere Connect20130—
+3K132148S HealthSamsung Electronics Co., Ltd.20130—
+3K131739Nxstage Connected Health SystemNxstage Medical, Inc.20131—
+3K124000Medapps 2.0 - Remote Patient Monitoring SystemMedapps Inc., Dba Alere Connect20134—
+3K111922Vocare Myhealth TabletVocare, Inc.20110—
+3K110316Infosend GSMFisher & Paykel Healthcare, Ltd.20111—
+3K110334Waldo Patient MonitorWaldo Health20111—
+3K101078BL Healthcare Remote Care Management SystemBl Healthcare, Inc.20101—
+4K181248Comarch e-Care PlatformComarch Healthcare SA20182—
+4K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+4K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+4K113493TCX-I Remote Care Management SystemBl Healthcare, Inc.20110—
+5K252440EasyTeleMed (2.0.2)Ingeniars S.R.L.20250—
+5K211822LifePath Remote Patient Monitoring PlatformElastic Care Incorporated20221—