FDA.reportPublic FDA data

dorsaVi - V6 Overwrap Adhesives

Primary DI
B758000RDA483
Brand
dorsaVi - V6 Overwrap Adhesives
Company
DORSAVI LTD
Model
V6 Overwrap Adhesives
Catalog number
RS-A483
Device description
Single use disposable application pad adhesive for use with dorsaVi Version 6 Sensors.
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B758000RDA483PrimaryHIBCC0
B75800RDA445Unit of UseHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius27 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
757139956
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B758000VMPLU0ViMove+000VMPLU0VMPLU2023-08-30
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

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04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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