510(k) Report

Devices descending from K983533

126 later devices reach Actiwatch through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+6K240236Happy Ring Health Monitoring SystemHappy Health, Inc.20240—
+6K240693LINQ II™ Insertable Cardiac Monitor (ICM)Medtronic, Inc.20241—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—
+6K233562LINQ II Insertable Cardiac MonitorMedtronic, Inc.202301
+6K212208Philips IntelliVue GuardianSoftware (Rev. E.0X)Philips Medizin Systeme Boeblingen GmbH20210—
+6K202189GraffitiGe Medical Systems Information Technologies, Inc.20200—
+6K200444Biomonitor III, Biomonitor IIImBiotronik, Inc.20204—
+6K183052ID-Cap SystemEtectrx, Inc.20190—
+6K191272Wearable Device, Wearable PackageCurrent Health, Ltd.201916—
+6K162855Reveal LINQMedtronic, Inc.2017111
+6K163460Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20170—
+7K262735LINQ II Insertable Cardiac Monitor (ICM) (LNQ22)Medtronic, Inc.20260—
+7K241397HinscopeHinlab Sas20240—
+7K213863Everion+ SystemBiofourmis Singapore Pte., Ltd.20231—
+7K222550Current Health SystemCurrent Health, Ltd.20221—
+7K210133Current Health Monitoring System Gen 2 (G2)Current Health20218—
+7K212008Reveal LINQ Insertable Cardiac MonitorMedtronic, Inc.20210—
+7K201865Biomonitor III, Biomonitor IIImBiotronik, Inc.20203—
+8K233418Biofourmis Everion+ (G2)Biofourmis Singapore Pte., Ltd.20240—
+8K232548Corsano CardioWatch 287-2 SystemCorsano Health B.V.20241—
+8K231506Current Health SystemCurrent Health, Ltd.20230—
+8K221856BIOMONITOR IIIm, BIOMONITOR IIIBiotronik, Inc.20222—
+9K261367Corsano CardioWatch 287-2 SystemCorsano Health B.V.20260—
+9K230375Biomonitor IVBiotronik, Inc.20231—
+10K261074Biomonitor IV (471155)Biotronik, Inc.20260—