FDA.reportPublic FDA data

Kinesiology ambulatory recorder

Definition
A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.
GUDID devices
52
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860010613320StrideLink MercuryStrideLink Inc.12024-12-16
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.Opal V2C2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.DOCK2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.AP2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.DataHub2024-08-30
00853048008053ActiGraphACTIGRAPH L.L.C.LEAP2024-04-24
00860007307515StepWatchModus Health LLCStepWatch52023-09-08
00860007307522StepWatchModus Health LLCStepWatch42021-08-23
00850023837042Opal DataHubERESEARCHTECHNOLOGY, INC.V2C2021-03-31
00850023837011Opal V2CERESEARCHTECHNOLOGY, INC.V2C2021-01-18
00850023837028Docking Station V2CERESEARCHTECHNOLOGY, INC.DSV2C2021-01-18
00850023837035Access Point V2CERESEARCHTECHNOLOGY, INC.APV2C2021-01-18
08500238370019Opal V2CERESEARCHTECHNOLOGY, INC.V2C2020-09-23
08500238370026Docking Station V2CERESEARCHTECHNOLOGY, INC.DSV2C2020-09-23
08500238370033Access Point V2CERESEARCHTECHNOLOGY, INC.APV2C2020-09-23
00606959057753ActiwareRespironics, Inc.Actiware, Software CD, US Gov. - 62020-05-14
B628APV2C0Access Point V2CAPDM, INC.V2C2019-12-30
B628DSV2C0Docking Station V2CAPDM, INC.V2C2019-12-30
B628OPALV2C0Opal V2CAPDM, INC.V2C2019-12-30
00190446286967DONJOYDJO, LLC11-4000-0-060002018-04-17
00190446286974DONJOYDJO, LLC11-4001-0-060002018-04-17
00190446293613RAW MATERIALDJO, LLC13-40242018-03-02
00606959003842Actiwatch 2Respironics, Inc.Actiwatch 2 System2016-09-19
00606959003897Actiwatch 2Respironics, Inc.Actiwatch 2 Device2016-09-19
00606959003903Actiwatch 2Respironics, Inc.Actiwatch 2 Communication Dock System2016-09-19
00606959021006ActicalRespironics, Inc.ACTICAL2016-09-19
00606959021013Actical SoftwareRespironics, Inc.3.112016-09-21
00606959021402ActiwatchRespironics, Inc.Actiwatch Spectrum Pro 2016-09-19
00606959021440ActiwatchRespironics, Inc.Actiwatch Spectrum Plus2016-09-19
00606959021457ActiwareRespironics, Inc.Actiware Software CD - 62016-09-02
00606959039872AcitwareRespironics, Inc.Actiware Software Web Download - 62016-09-02
00606959040366ActiwareRespironics, Inc.Actiware Clinical Trial Software, English - 62016-09-15
00606959042032Actiwatch Spectrum ProRespironics, Inc.Actiwatch Spectrum PRO Japan2016-09-19
00606959042049Actiwatch Spectrum PlusRespironics, Inc.Actiwatch Spectrum Plus, Japan2016-09-19
00606959042056Actiwatch 2Respironics, Inc.Actiwatch 2 Docking Station2016-09-19
00606959043855ACTIWATCH 2Respironics, Inc.Actiwatch 2 Device2016-10-12
00606959043862Actiwatch 2Respironics, Inc.Actiwatch 2 Dock Sub Assembly2016-10-12
00853048008008ActigraphACTIGRAPH L.L.C.wGT3X-BT2017-12-28
00853048008015ActiGraphACTIGRAPH L.L.C.GT9X2017-12-28
00853048008039ActiGraphACTIGRAPH L.L.C.CentrePoint Insight Watch2018-10-16
05060481691666DataLOG MWX8BIOMETRICS LIMITEDMWX82018-08-10
05060481691673DataLOG Management Software (Version 10)BIOMETRICS LIMITED410xx-002018-08-10
05060481691680DataLOG Management + Analysis Software (Version 10)BIOMETRICS LIMITED410xx-112018-08-10
05060481691789DataLOG MWX8BIOMETRICS LIMITEDMWX82018-08-10
20884838064953Philips Wearable BiosensorPhilips Medical Systems Hsg9898031968612016-11-25
20884838064960Philips Wearable BiosensorPhilips Medical Systems Hsg9898031968712016-11-25
B329AWVM33ActiwaveCAMNTECH LIMITEDMotion2016-09-24
B329MW850MotionWatchCAMNTECH LIMITEDMW82016-09-24
B329MWR50MotionWatchCAMNTECH LIMITEDMW-R2018-11-02
B329PDM25PRO-DiaryCAMNTECH LIMITEDPDM2016-09-24
B329PDV25PRO-DiaryCAMNTECH LIMITEDPDV2019-08-29
B493MC0011Kintinuum™MC10, INC.MC-00112019-02-01