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

    REPROCESSED COMPRESSION SLEEVE

    K Number: K021654 · Decision Feb 5, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    11
    Review Days
    261

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    REPROCESSED COMPRESSION SLEEVE
    K Number
    K021654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alliance Medical, Inc.
    Date Received
    May 20, 2002
    Decision Date
    February 5, 2003
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

    Similar 510(k) Clearances

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

    Compression Therapy Device (LGT-2202DVT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NanoPress 760A-BT (760A-BT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Bio Arterial Deluxe (IC-BAP-DX)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sequential Compression System (SCD600)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PlasmaFlow X Compression Sleeve Device (XPF0001)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Alliance Medical, Inc.

    K Number Device Name
    K051438 VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM)
    K050518 REPROCESSED PHACOEMUISIFICATION TIPS
    K030187 REPROCESSED ELECTROPHYSIOLOGY CATHETER
    K012634 REPROCESSED EXTERNAL FIXATION DEVICE
    K012630 REPROCESSED LINVATEC ARTHROSCOPIC BURS
    K012611 REPROCESSED DYONICS ARTHROSCOPIC SHAVERS
    K012613 REPROCSSED LINVATEC SHAVERS
    K990198 AMIB7
    K951976 ECHO. AKHO
    K931091 DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252
    Search all 11 clearances from Alliance Medical, Inc. →