FDA.reportPublic FDA data

U400 ImpSoft Software

Primary DI
B277292U400CD0
Brand
U400 ImpSoft Software
Company
IMPEDIMED LIMITED
Model
2.2.0
Catalog number
292-U400CD
Device description
Impsoft data management & analysis software
Published
2017-02-13
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
OBHMonitor, Extracellular Fluid, Lymphedema, Extremity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBHMonitor, Extracellular Fluid, Lymphedema, ExtremityCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080825000IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400Impedimed Pty , Ltd.2008-10-03OBH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B277292U400CD1PackageHIBCC1
B277292U400CD2PackageHIBCC1
B277292U400CD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Regulatory Flags#

DUNS number
757258843
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B277222LDEXU4000L-Dex® U400U400222-LDEXU4002017-02-13
B277223DF500Imp DF50DF50223-DF502017-02-13
B277223SFB70Imp SFB7SFB7223-SFB72017-02-13
B277229DF500Imp DF50DF50229-DF502017-02-13
B277229SFB70Imp SFB7SFB7229-SFB72017-02-13
B27724269950SOZO Body Fluid Analyzer2426995242-SOZO2018-05-01
B277242LDEXU4000L-Dex® U400U400242-LDEXU4002017-02-13
B277243DF500Imp DF50DF50229-DF502017-02-13
B277243SFB70Imp SFB7SFB7243-SFB72017-02-13
B277249DF500Imp DF50DF50229-DF502017-02-13
B277252LDEXU4000L-Dex® U400U400242-LDEXU4002017-02-13
B277253DF500Imp DF50DF50229-DF502017-02-13
B277253SFB70Imp SFB7SFB7253-SFB72017-02-13
B277259DF500Imp DF50DF50229-DF502017-02-13
B277259SFB70Imp SFB7 SFB7259-SFB72017-02-13
B27728269950SOZO Body Fluid Analyzer282699528269952022-05-16
B277292BCE1Body Composition Dual Tab Electrode292-BCE292-BCE2017-02-13
B277292DF50CD0Body Composition Analysis Software4.1.2292-DF50CD2017-02-13
B277292STE1Single Tab Electrode292-STE292-STE2017-02-13
B277299SFB7CD0BioImp Body Composition Analysis Software SFB7 5.5.0.1299-SFB7CD2017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B277SFT0250MYSOZO.com IMPEDIMED LIMITEDOBH2023-08-03
B27728269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2022-05-16
B27728269951SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2022-05-16
B27727269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2019-09-12
B277SOZOAPP0SOZOapplicationIMPEDIMED LIMITEDOBH2019-08-01
B27724269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2018-05-01
B27724269952SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2018-05-01
B27725269950SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2018-05-01
B27727270000SOZO Body Fluid AnalyzerIMPEDIMED LIMITEDOBH2017-10-02
B277SOZOTHRIVE0SOZOThriveIMPEDIMED LIMITEDOBH2017-10-02
B277222LDEXU4000L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277242LDEXU4000L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277252LDEXU4000L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277222LDEXU4002L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277242LDEXU4002L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B227252LDEXU4002L-Dex® U400IMPEDIMED LIMITEDOBH2017-02-13
B277292U400CD2U400 ImpSoft SoftwareIMPEDIMED LIMITEDOBH2017-02-13