FDA.reportPublic FDA data

MyoVision Wirefree System

Primary DI
00853818007019
Brand
MyoVision Wirefree System
Company
PRECISION BIOMETRICS INC
Model
D3-D5-D6-D7
Catalog number
D3-D5-D6-D7
Device description
PhysioMonitor Hub with Flexvision Inclinomters DynaVision Dynamic sEMG and ScanVision Static sEMG Scaners
Published
2016-11-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback
HCSDevice, Temperature Measurement, Direct Contact, Powered
IKNElectromyograph, Diagnostic
KQXGoniometer, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2
HCSDevice, Temperature Measurement, Direct Contact, PoweredNeurology2
IKNElectromyograph, DiagnosticPhysical Medicine2
KQXGoniometer, Ac-PoweredOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123399000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123399000MYOVISION 3.0 WIREFREE SYSTEMPrecision Biometrics, Inc.2013-08-01IKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853818007019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853818007019008538180070198538180070190853818007019

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological signal amplifierAn electronic device that increases current, voltage, or power to adjust the signal level and impedance between two or more medical devices transmitting physiological signals; or the device has the capability of being used for more than a single application, such as electroencephalography (EEG), evoked potential, polysomnography (sleep analysis) and general polygraphy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
362997926
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853818007262DynaVision BeltsPB-2942016-12-19
10853818007504USB C AdapterPB-210-12024-09-03
00853818007491USB A to C CablePB-209PB-2092024-09-03
00853818007507USB C to C CablePB-2102024-09-03
00853818007286Dynamic Lead Wire SetPB-402016-12-13
00853818007477MyoVision SoftwareFeature Pack H2022-11-10
00853818007460MyoVision Wirefree SystemD2-D6D2-D62021-05-17
00853818007422SERIES-5 MyoVision Full SystemD2-D5-D6-D7LD2-D5-D6-D7L2021-02-28
00853818007439SERIES-5 MyoVision ScanVisionD2-D7D2-D72021-02-28
00853818007446SERIES-5 MyoVision ScanVisionD2-D7-D7D2-D7-D72021-02-28
00853818007453SERIES-5 MyoVision FlexVision SystemD2-D5D2-D5-D52021-02-28
00853818007224ScanVision electrodesPB-2122016-12-13
00853818007415MyoVision Wirefree SystemD2-D5-D6D2-D5-D62021-01-05
00853818007330USB ChargerPB-2052017-02-20
00853818007057MyoVision SoftwareApricot2016-11-27
00853818007064MyoVision SoftwareFeature Pack A2016-11-27
00853818007071MyoVision SoftwareFeature Pack B2016-11-27
00853818007088MyoVision SoftwareFeature Pack C2016-11-27
00853818007095MyoVision SoftwareFeature Pack D2016-11-27
00853818007101MyoVision SoftwareFeature Pack E2016-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884400829658Hubble-24AMAZE Neuro, Inc.HCC2026-08-27
00884400833297Voyager-7AMAZE Neuro, Inc.HCC2026-08-27
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 INCHCC2024-09-03
10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
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