510(k) Report

Devices descending from K952882

142 later devices reach Personal Telemedicine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K061328Think Positive Diabetes Management System (T+Diabetes System)E-San Limited200624—
+6K202483MyHomeDocMyhomedoc, Ltd.20211—
+6K191745Medtronic Commander FlexMedtronic Care Management Services20200—
+6K181612Tyto Stethoscope (OTC)Tyto Care, Ltd.201819—
+6K181991NxStage Connected Health SystemNxstage Medical, Inc.20180—
+6K163664Health-e-Connect System with IDAAlr Technologies20170—
+6K161686F&P InfoSmartFisher & Paykel Healthcare, Ltd.20170—
+6K150782AbStats GatewayGi Logic, Inc.20152—
+6K121738Myvisiontrack (TM)Vital Art and Science Incorporated20133—
+6K123229Remote Presence System, Model RP-VitaIntouch Health, Inc.20120—
+6K101806Aidera Diasend SystemAidera AB20102—
+6K093789Intouch DiabetesSymcare Personalized Health Solutions, Inc.20100—
+6K091296Polytel Gma, Models PWR-08-67, PWR-08-07, PWR-08-09Polymap Wireless20090—
+6K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc.20091—
+6K081499Health Manager, Version 1.1Biocomfort Diagnostics GmbH & Co. KG20090—
+6K083331Confidant, Model 2.6Confidant, Inc.20092—
+7K252089Tyto Stethoscope (G3)Tyto Care, Ltd.20260—
+7K252474Withings BeamO (SCT02)Withings20250—
+7K223785N9+Nonagon, Ltd.20230—
+7K212906HeartBuds Electronic StethoscopeHeartbuds, LLC20230—
+7K223166Medaica M1 Telehealth StethoscopeMedaica, Inc.20230—
+7K211068PrevisEA DeviceEntac Medical, Inc.20211—
+7K200776Eko COREEko Devices, Inc.202013—
+7K143211myVision Track Model 005Vital Art and Science Incorporated20152—
+7K132618Onetouch RevealLifescan, Inc.20130—
+7K122361T:Connect Data Management SystemTandem Diabetes Care, Inc.20130—
+8K261694CORE 300 Digital StethoscopeEko Health, Inc.20260—
+8K233313Keikku Electronic stethoscopeLapsi Health Holding B.V.20240—
+8K231551StethophoneSparrow Acoustics, Inc.20232—
+8K230613SkeeperSmartsound Corporation20230—
+8K230769PrevisEA DeviceEntac Medical, Inc.20230—
+8K220099eClinic StethopodHomediagnostic, LLC20220—
+8K220470Smart Wireless StethoscopeShanghai Hulu Devices Co., Ltd.20221—
+8K220196Steth IO SpotStratoscientific20220—
+8K210736doctorgram Stethoscope DES-IGv Concepts20212—
+8K180895AlleyeOculocare Medical AG20181—
+9K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…Shanghai Hulu Devices Co., Ltd.20260—
+9K240901StethophoneSparrow Acoustics, Inc.20241—
+9K203594EyeCTesterNeuro-Eye Diagnostic Systems, LLC20220—
+9K212975MedWandMedwand Solutions, Inc.20221—
+10K253436c-med0 alphaCosinuss GmbH20260—
+10K252595Stethophone ProSparrow Acoustics, Inc.20250—