FDA.reportPublic FDA data

Myovision Charging Cable

Primary DI
00853818007309
Brand
Myovision Charging Cable
Company
PRECISION BIOMETRICS INC
Model
PB-220
Catalog number
PB-220
Device description
PB-220 Myovision Charging Cable
Published
2016-12-31
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
00853818007309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853818007309008538180073098538180073090853818007309

GMDN Terms#

Term, Definition table
TermDefinition
Electrical mains power cableAn insulated electrical cord designed to enable connection of a medical device to a mains electricity supply socket, with a male and a female connector (plug) at either end. It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
362997926
Device count
1

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
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
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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