FDA.reportPublic FDA data

dorsaVi - V6 EMG DAP

Primary DI
B75800RDA865
Brand
dorsaVi - V6 EMG DAP
Company
DORSAVI LTD
Model
V6 EMG DAP
Catalog number
RS-A865
Device description
Single use disposable application pad adhesive for use with dorsaVi Version 6 EMG Sensors.
Published
2023-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
B758000RDA890PrimaryHIBCC0
B75800RDA865Unit 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
757139956
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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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04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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04560340091824Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020896UltiumNoraxon U.S.A., Inc.HCC2026-03-30