BEUDAMED
    Product Code: OBH FDA class 2 21 CFR 870.2770

    Monitor, Extracellular Fluid, Lymphedema, Extremity

    Cardiovascular

    The Extracellular Fluid Lymphedema Monitor for Extremities (product code OBH) is a non-invasive cardiovascular device that measures bioimpedance in affected and unaffected opposite extremities to periodically monitor extracellular fluid levels in patients previously diagnosed with unilateral lymphedema. By comparing impedance differences between opposing limbs, clinicians can track disease progression and guide therapy. This device is FDA Class 2, requiring 510(k) clearance and compliance with general and special controls under regulation 870.2770 in the Cardiovascular specialty. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    10
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    3
    Years Active
    19

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    Basic Information

    Product Code
    OBH
    Device Class
    FDA class 2
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Measure impedances in affected and unaffected but opposite extremity to periodically monitor the level of extracellular fluid or the differences in bioimpedance between opposing extremities for patients who have been previously diagnosed with unilateral lymphedema (that is, in one affected extremity)

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 10 510(k) clearances via K numbers.

    K Number Device Name
    K253224 MySOZO Software version 6.0.1.2 (SW version 6.0.1.2)
    K230530 SOZO Pro
    K220557 MoistureMeterD Compact, LymphScanner
    K180126 SOZO
    K172122 SOZO
    K143310 MoisturemeterD
    K130338 IMPEDIMED - BIS EXTRA CELLULAR FLUID ANALYSIS
    K100811 IMPEDIMED - EXTRACELLULAR FLUID ANALYZER MODEL: L-DEX U400
    K080825 IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400
    K050415 IMPEDIMED-EXTRACELLULAR FLUID ANALYSIS

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.