FDA.reportPublic FDA data

PRO-Diary

Primary DI
B329PDV25
Brand
PRO-Diary
Company
CAMNTECH LIMITED
Model
PDV
Catalog number
05-121
Device description
Ambulatory Physical Activity Recorder with Electronic Patient diary
Published
2019-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LELDevice, Sleep Assessment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LELDevice, Sleep AssessmentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132764000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132764000MOTION WATCH AND PRO-DIARYCamntech, Ltd.2014-01-21LEL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B329PDV25PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 830-755-8036sales@camntech.com

Regulatory Flags#

DUNS number
399114941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B329AH420ActiheartAH408-3052016-09-24
B329AWV01E22Actiwave1E08-5142016-09-24
B329AWV02E25Actiwave2E08-5212016-09-24
B329AWV02M25Actiwave2M08-5362016-09-24
B329AWV04E22Actiwave4E08-5572016-09-24
B329AWVC23ActiwaveCardio08-6032016-09-24
B329AWVM33ActiwaveMotion08-5652016-09-24
B329MW850MotionWatchMW804-1112016-09-24
B329MWR50MotionWatchMW-R04-1212018-11-02
B329PDM25PRO-DiaryPDM05-1112016-09-24
B329AH556ActiheartAH518-5002019-08-29
B329AHBT56ActiheartAH5 BT18-5052019-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00853858006522EmbraceMiniEMPATICA SRLLEL2026-02-16
00853858006546Empatica Health Monitoring PlatformEMPATICA SRLLEL2026-02-16
00853858006713EmbraceMiniEMPATICA SRLLEL2026-02-16
00853858006751Empatica Health Monitoring PlatformEMPATICA SRLLEL2026-02-16
00853858006584EmpaticaEMPATICA SRLLEL2025-06-26
00850068747092Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747108Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747115Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747122Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747139Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747146Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747153Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747160Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
00850068747177Happy HealthHAPPY HEALTH, INC.LEL2025-04-02
50607514500023Oxevision Sleep systemOXEHEALTH LIMITEDLEL2025-01-21
00853858006379EpiMonitorEMPATICA SRLLEL2024-08-14
00853858006386EpiMonitorEMPATICA SRLLEL2024-08-14
B1400532XA0BRAEBON Ultima Body Position SensorBraebon Medical CorporationLEL2024-07-12
B1400533XA0BRAEBON Ultima Body Position Sensor for Alice 5Braebon Medical CorporationLEL2024-07-12
00853048008053ActiGraphACTIGRAPH L.L.C.LEL2024-04-24
00860008932204Spire Health Remote Patient Monitoring SystemCONVEXITY SCIENTIFIC LLCLEL2023-01-03
00853858006232Empatica Health Monitoring PlatformEMPATICA SRLLEL2022-11-24
00853858006249Empatica Health Monitoring PlatformEMPATICA SRLLEL2022-11-24
00853858006256Empatica Health Monitoring PlatformEMPATICA SRLLEL2022-11-24
00853858006263Empatica Health Monitoring PlatformEMPATICA SRLLEL2022-11-24
G012BRCA02BioStamp® nPointMedidata Solutions, Inc.LEL2021-04-01
G012BRCA05BioStamp®Medidata Solutions, Inc.LEL2021-04-01
G012BRCD02BioStamp®Medidata Solutions, Inc.LEL2021-04-01
G012BRCP01BioStamp nPoint™Medidata Solutions, Inc.LEL2021-04-01
G012BRCP02BioStamp® nPointMedidata Solutions, Inc.LEL2021-04-01