FDA.reportPublic FDA data

Actigraph

Primary DI
00853048008008
Brand
Actigraph
Company
ACTIGRAPH L.L.C.
Model
wGT3X-BT
Device description
The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT is intended for use in applications where quantifiable measurement and storage of physical movement is desired.
Published
2017-12-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080545000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080545000ACTITRAINERActigraph, LLC2008-07-24ISD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853048008008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853048008008008530480080088530480080080853048008008

GMDN Terms#

Term, Definition table
TermDefinition
Kinesiology ambulatory recorderA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature-10 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144830952
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853048008053ActiGraphLEAPLEAP2024-04-24
00853048008015ActiGraphGT9X2017-12-28
00853048008039ActiGraphCentrePoint Insight WatchCPW012018-10-16
00853048008022ActiGraphCentrePoint Data Hub2017-12-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05065013876061Sword ThriveSWORD HEALTH, S.A.ISD2026-06-02
08717524641085Lode B.V.Lode B.V.ISD2026-06-01
08717524641092Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
00850064651058DS6Foresite Healthcare, LLCISD2024-05-24