BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET

    K Number: K121106 · Decision Apr 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    99
    Registration Numbers
    99
    Same Product Code
    63
    Applicant Total
    9
    Review Days
    15

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    Basic Information

    Device Name
    TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET
    K Number
    K121106
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5780
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Appliance Industries, Inc.
    Date Received
    April 12, 2012
    Decision Date
    April 27, 2012
    Product Code
    DWL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DWL), ordered by most recent decision date.

    MEDLINE ANTI-EMBOLISM STOCKING

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    BELLAVAR / CUSTOM SEAMLESS SOFT (A.K.A. COMTESSE)

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    ENCIRCLE COMPRESSION THERAPY STOCKING

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    BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS

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    FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Surgical Appliance Industries, Inc.

    K Number Device Name
    K821682 TRUNCAL ORTHOSIS
    K813416 EXTERNAL BREAST PROSTHESIS
    K812423 NEOPRENE KNEE SUPPORT
    K812401 CRUCIFORM ANTERIOR SPINAL HYPEREXTEN. O
    K812422 CUSTOM CONTOUR LUMBOSACRAL ORTHOSIS
    K811689 CYLINDER KNEE CAST/SPLINT
    K811690 ANKLE-FOOT CAST/SPLINT
    K811494 LUMBO-SACRAL FLEXION ORTHOSIS