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

    COLLINS PEDALMATE 2

    K Number: K781889 · Decision Nov 22, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    60
    Applicant Total
    14
    Review Days
    15

    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
    COLLINS PEDALMATE 2
    K Number
    K781889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5360
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Warren E. Collins, Inc.
    Date Received
    November 7, 1978
    Decision Date
    November 22, 1978
    Product Code
    ISD
    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
    ISD Exerciser, Measuring

    Similar 510(k) Clearances

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

    MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    REAL Immersive System

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ActiSpec Activity Monitor

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ERGOSELECT/GE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ACTITRAINER

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ERGOSELECT 100 K/P, ERGOSELECT 200 K/P

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

    Other Clearances by Warren E. Collins, Inc.

    K Number Device Name
    K925459 GS-MODULAR (GOLD STANDARD - MODULAR)
    K912946 COLLINS DIGITAL PULMONARY MANOMETER
    K871151 THE SPIRA ELEKTRO 2
    K861227 COLLINS PNEUMOTACH PFT SYSTEM
    K852102 COLLIN BODY PLETHYSMOGRAPH PLUS SYSTEM
    K831780 METABOLIC EXERCISE TESTING SYSTEM
    K831777 COLLINS DS
    K831778 RS-RESIDUAL VOLUME SYSTEM
    K831779 COLLINS EAGLE II
    K803053 APEXLINE OF PULMONARY FUNCT. INSTRUM.
    Search all 14 clearances from Warren E. Collins, Inc. →