FDA.reportPublic FDA data

ViMove+

Primary DI
B758000VMPLU0
Brand
ViMove+
Company
DORSAVI LTD
Model
000VMPLU0
Catalog number
VMPLU
Device description
ViMove+ is a wireless medical device that measures, records, and reports movements and muscle activity of the lowerback / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
Published
2023-08-30
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
HCCDevice, Biofeedback
IKNElectromyograph, Diagnostic
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163150000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163150000ViMove2Dorsavi, Ltd.2017-07-14IKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B758000VMPLU0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+611800367728support@dorsavi.com

Regulatory Flags#

DUNS number
757139956
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B758000RDA483dorsaVi - V6 Overwrap AdhesivesV6 Overwrap AdhesivesRS-A4832023-08-30
B758000RDA890dorsaVi - V6 EMG DAPV6 EMG DAPRS-A8652023-08-30
B758000RDA891dorsaVi - V6 Low Back AMI DAPV6 Low Back AMI DAPRS-A8662023-08-30
B75800RDA445dorsaVi - V6 Overwrap AdhesivesV6 Overwrap AdhesivesRS-A4832023-08-30
B75800RDA865dorsaVi - V6 EMG DAPV6 EMG DAPRS-A8652023-08-30
B75800RDA866dorsaVi - V6 Low Back AMI DAPV6 Low Back AMI DAPRS-A8662023-08-30
B75800003563030 Minute Disposable Application Pad30Min-DAP0356-302019-09-26
B7580000PS100Professional Suite0000PS100PS1002019-09-26
B7580000VMV50Movement Suite / V5 Sensor Kit0000VMV50VMV502019-09-26
B758000RDA482dorsaViV6 Sensor AdhesiveRS-A4822020-08-04
B7580000RDA482000000000dorsaViV6 Sensor AdhesiveRS-A4822020-08-04
B7580000PS100000000000Professional Suite0000PS100000000000PS1002019-09-26
B7580000VMV50000000000Movement Suite / V5 Sensor Kit0000VMV50000000000VMV502019-09-26
B758035630000000000000130 Minute Disposable Application Pad30Min-DAP0356-302019-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860015825803JOGO-GxJogohealth, Inc.HCC2026-07-27
00860007286513KinetigramBioniksKQX2026-07-22
07540191000678NeuroInfinitiThought Technology Ltd.HCC2026-07-06
G345SL2000CIONICCionic, Inc.HCC2026-06-04
00190376509747SafeOp 3ALPHATEC SPINE, INC.IKN2026-03-24
08719481550110NeXus 10 MK3Mind Media Europe B.V.HCC2025-09-10
08056446901106NExT-DOCKINGEB NEURO SPAIKN2025-05-22
08056446901113NExT-PADEB NEURO SPAIKN2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAIKN2025-05-22
08056446901137NExT-HSEB NEURO SPAIKN2025-05-22
08056446901168NExT-AMPEB NEURO SPAIKN2025-05-22
08056446901199NExT-ASEB NEURO SPAIKN2025-05-22
08056446901205NExT StationEB NEURO SPAIKN2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAIKN2025-05-19
50885380198791KangarooCardinal Health 200, LLCHCC2025-03-12
00190376517506SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
00190376530024SafeOp 3ALPHATEC SPINE, INC.IKN2024-11-12
10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
10853818007504USB C AdapterPRECISION BIOMETRICS INCHCC2024-09-03
08592566001208Disposable blunted needlesDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566419003TruScan Neurofeedback AdapterDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566431395TruScan LT 24 Neurofeedback headboxDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566432392TruScan LT 32 Neurofeedback headboxDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566449000TruScan Neurofeedback optical cable V3.3LDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566509001TruScan Neurofeedback AcquisitionDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566509506TruScan Neurofeedback ExplorerDEYMED Diagnostic s.r.o.HCC2023-10-26
08592566639005Ear Electrode Sn (Tin)DEYMED Diagnostic s.r.o.HCC2023-10-26
08592566639012Ear Electrode Sn (Tin)DEYMED Diagnostic s.r.o.HCC2023-10-26
08592566639029Ear Electrode Sn (Tin)DEYMED Diagnostic s.r.o.HCC2023-10-26
08592566639234Headbox Safety Ribbon Cable for Cap ConnectionDEYMED Diagnostic s.r.o.HCC2023-10-26