BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PATIENT GUIDED KNEE EXERCISER

    K Number: K820120 · Decision Jan 29, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    159
    Applicant Total
    48
    Review Days
    11

    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
    PATIENT GUIDED KNEE EXERCISER
    K Number
    K820120
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5380
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Richard'S Medical Equip., Inc.
    Date Received
    January 18, 1982
    Decision Date
    January 29, 1982
    Product Code
    BXB
    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
    BXB Exerciser, Powered

    Similar 510(k) Clearances

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

    G-TRAINER MEDICAL

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    FLO-BOOT

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ANKLE CALF EXERCISER PHLEBOPUMP

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    E-Z FLEX

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTE CPM-20

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTE CPM-10

    FDA 510(k)
    FDA Class 1 ·Physical Medicine
    View all

    Other Clearances by Richard'S Medical Equip., Inc.

    K Number Device Name
    K830793 PATIENT GUIDED ELBOW & SHOULDER EXERC
    K823837 RMC TOTAL KNEE SYSTEM
    K823726 SPECTRON CONVERSION ENDOPROSTHESIS CUP
    K823724 SPECTRON NECK REPLACEMENT PROSTHESIS
    K823723 SPECTRON PROXIMAL FEMORAL PROSTHESIS
    K823722 SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
    K823727 SPECTRON PRIMARY STEM FEMORAL PROSTHES
    K830153 RICHARDS INTRA-ARTICULAR SHAVER BLADES
    K830154 COLLES FRACTURE FRAME
    K823725 SPECTRON PROTRUSIO CUP
    Search all 48 clearances from Richard'S Medical Equip., Inc. →