FDA.reportPublic FDA data

Dynamic Lead Wire Set

Primary DI
00853818007286
Brand
Dynamic Lead Wire Set
Company
PRECISION BIOMETRICS INC
Model
PB-40
Device description
"40"" Dynamic Lead Wire Set (WireFree)"
Published
2016-12-13
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
00853818007286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853818007286008538180072868538180072860853818007286

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous leadAn insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), bioelectrical impedance]. It is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). 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
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
00853818007392MyoVision SoftwareFeature Pack G2018-04-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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