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

    G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S

    K Number: K850851 · Decision Jun 25, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    759
    Registration Numbers
    759
    Same Product Code
    99
    Applicant Total
    10
    Review Days
    116

    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
    G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S
    K Number
    K850851
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5660
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Physio Technology, Inc.
    Date Received
    March 1, 1985
    Decision Date
    June 25, 1985
    Product Code
    ISA
    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
    ISA Massager, Therapeutic, Electric

    Similar 510(k) Clearances

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

    VMAT PRO

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    ShockPhysio Mobile (model SW3200 Basic)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BTL-094

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    Omnispec ED1000

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    OW100S (model OW100S-US)

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DolorClast Radial

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

    Other Clearances by Physio Technology, Inc.

    K Number Device Name
    K883893 OMNISOUND(TM) 3000
    K874076 MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR
    K861039 OMNIVAC (VACUUM ELECTRODE SYSTEM)
    K850850 AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR
    K850849 MYOMETER EMG BIOFEEDBACK DEVICE
    K843351 OMNISTIM II COMBIN. THERAPY SYS
    K843372 OMNISOUND THERAPY UNIT
    K841874 MEGA PULSE THERAPY UNIT
    K841278 OMNISTIM III INTERFERENTIAL THERAPY