510(k) Report

Devices descending from K991033

35 later devices reach Actiwatch-Score through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132764Motion Watch and Pro-DiaryCamntech, Ltd.201410—
+1K093976Raisin Personal MonitorProteus Biomedical, Inc.201012—
+1K063872KinesiaCleveland Medical Devices, Inc.200710—
+2K233987Veraband™Arbor Medical Innovations, LLC20240—
+2K173510BioStamp nPointMc10, Inc.20180—
+2K151784ActTrustCondor Instruments Ltda. - Epp20160—
+2K142476Master Caution Device MCDHealthwatch, Ltd.20156—
+2K140086Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20149—
+2K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20136—
+2K110015Vitalsens, Aingeal, V-PodIntelesens Limited20114—
+3K213519Rune Labs Tremor Transducer SystemRune Labs, Inc.20224—
+3K173248CardioskinBioserenity Sas20180—
+3K161431SimplECGNanowear, Inc.20165—
+3K161717Personal Kinetigraph (PKG) SystemGkc Manufacturing Pty, Ltd.20163—
+3K153275Aingeal Activity SystemIntelesens, Ltd.20160—
+3K151027zensor systemIntelesens Limited20150—
+3K132407Vital Signs Patch System (in Short VSP)Lifewatch Technologies, Ltd.20141—
+3K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc.20144—
+3K131524Proteus Patch Including Ingestible SensorProteus Digital Health, Inc.20130—
+4K253055Sine Monitoring Parkinson’s Disease Tremor Dyskinesia Apple Watch (“SMPDTDAW”)Nordic Kinetics AB20260—
+4K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc.20231—
+4K221772NeuroRPMNew Touch Digital, Inc.20230—
+4K220820Parky AppH2o Bilisim Yazilim20223—
+4K211887Personal Kinetigraph (PKG) System Gen 2 PlusGkc Manufacturing Pty, Ltd.20221—
+4K201669SimpleSENSENanowear, Inc.20203—
+4K151835Vital Signs Patch SystemLifewatch Technologies, Ltd.20160—
+4K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc.20153—
+5K262515Kneu Platform (V2)Kneu Health Digital, Ltd.20260—
+5K260374Empatica Health Monitoring Platform for Parkinson's Disease Monitoring; EmbracePlus…Empatica S.r.l.20260—
+5K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.20250—
+5K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc.20250—
+5K250153Neu PlatformNeuhealth Digital, Ltd.20251—
+5K212160SimpleSENSE PlatformNanowear, Inc.20211—
+5K183052ID-Cap SystemEtectrx, Inc.20190—
+6K232053SimpleSense-BP, SimpleSense-BP Software ApplicationNanowear, Inc.20230—