FDA.reportPublic FDA data

Power Supply for WireFree

Primary DI
00853818007293
Brand
Power Supply for WireFree
Company
PRECISION BIOMETRICS INC
Model
PB-204
Device description
Power Supply for WireFree System Hubs (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
00853818007293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853818007293008538180072938538180072930853818007293

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

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10853818007504USB C AdapterPRECISION BIOMETRICS INCKQX2024-09-03
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