FDA.reportPublic FDA data

Movement Suite / V5 Sensor Kit

Primary DI
B7580000VMV50000000000
Brand
Movement Suite / V5 Sensor Kit
Company
DORSAVI LTD
Model
0000VMV50000000000
Catalog number
VMV50
Device description
Movement Suite is a wireless medical device that measures, records, and reports movements and muscle activity of the lower back / lumbar spine. The system also measures range of motion in the sagittal and coronal anatomical planes.
Published
2019-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQXGoniometer, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7580000VMV50000000000PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B758000VMPLU0ViMove+000VMPLU0VMPLU2023-08-30
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
B758035630000000000000130 Minute Disposable Application Pad30Min-DAP0356-302019-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850004866320ActivForce 2ActivBody, Inc.KQX2026-09-14
00860007286513KinetigramBioniksKQX2026-07-22
08600157703018TGCT & MeREMEPY HEALTH LTDKQX2026-05-24
00816271020698UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020803myoRESEARCHNoraxon U.S.A., Inc.KQX2026-03-30
00816271020865UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271020872UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021039UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021046UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021053UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021060UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021077UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021084UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021091UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021107UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021114UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021121UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021138UltiumNoraxon U.S.A., Inc.KQX2026-03-30
00816271021145UltiumNoraxon U.S.A., Inc.KQX2026-03-30
04260242060316DIERS free²moveDIERS International GmbHKQX2026-03-09
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.KQX2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.KQX2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.KQX2025-10-23
00850004866184ActivForce 2ActivBody, Inc.KQX2025-09-03
05694230564002NeckCare AssessmentsNeckCare Holding ehfKQX2025-05-30
05694230564033NeckCare DeviceNeckCare Holding ehfKQX2025-05-30
09413000126259myDigitalKnee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-03-25
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09413000123395Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15
09413000123418Digital Knee®OPUM TECHNOLOGIES SERVICES LIMITEDKQX2025-01-15