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

    INTERSTIM 100 SYSTEM

    K Number: K861136 · Decision Jul 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    111
    Review Days
    105

    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
    INTERSTIM 100 SYSTEM
    K Number
    K861136
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Buckman Co., Inc.
    Date Received
    March 26, 1986
    Decision Date
    July 9, 1986
    Product Code
    IPF
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IPF Stimulator, Muscle, Powered

    Similar 510(k) Clearances

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

    Apollo Quattro (APQ-10M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    High Tone Power therapy (HiToP) (Model: HiToP PNP)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    StimelMD (SSMD) system

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Compact II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    EVE Synergy (EVE-20M)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TrainFES Advance

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Buckman Co., Inc.

    K Number Device Name
    K961320 CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
    K974641 FUTURELASE 3000/3002 ERBIUM LASER SYSTEM
    K964252 ORTHOCHUCK
    K950099 SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM
    K960451 WEBB-MORLEY SPINE SYSTEM
    K950999 KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS
    K945756 IMAGN(TM) 2000 SYSTEM
    K940003 VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT
    K951117 LIHTAN 532 LASER
    K942751 VANGUARD SERIES GAS REGULATORS
    Search all 111 clearances from Buckman Co., Inc. →