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510(k) Data Aggregation

    K Number
    K162412
    Device Name
    Hoggan Scientific® microFET2™
    Manufacturer
    Hoggan Scientific, LLC
    Date Cleared
    2017-03-09

    (192 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The microFET2™ System is a dynamometer device for performing muscle tests to quantitatively measure muscle weakness caused by injury or for sports medicine applications, as well as measure general muscle strength. The device is used to record and convey an individual's ability to resist force for a specific muscle group being tested.
    Device Description
    The microFET2™ is an ergonomically designed hand-held, battery operated, digital muscle tester. Which is an accurate, portable Force Evaluation Testing (FET) dynamometer, designed specifically for taking objective, reliable, and quantifiable muscle testing measurements, and is used to record a person's ability to resist force for a specific muscle or muscle group being tested. The device's ergonomic design allows for its use ambidextrously, depending on stabilization requirements, by being held in either hand using an elastic strap for convenience and comfort. The size and weight of the device allows the examiner/tester to use the same procedures and methods of muscle testing techniques without causing injury to the clinician or patient.
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    K Number
    K073154
    Device Name
    FACTS HAND AND PINCH GRIP COMBO
    Manufacturer
    GLOBAL SERVICES GROUP, LLC
    Date Cleared
    2008-02-14

    (98 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K052309
    Device Name
    DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
    Manufacturer
    SAEHAN CORP.
    Date Cleared
    2005-09-27

    (34 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.
    Device Description
    5.1 Digital Hand Dynamometer(SH5003) In health care environment, accurate and objective data is required for reimbursable rehabilitation services, making the SAEHAN Digital Hand Dynamometer an indispensable tool. Ideal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction. Virtually leak-proof hydraulics and isometric design ensure accurate, reproducible results and years of reliable service. A shock-resistant rubber cap protects the stainless steel gauge and a wrist strap prevents accidental damage if dropped. The SAEHAN Digital Hand Dynamometer combines Precision with convenient features: -Dual-scale readout displays isometric grip force from 0-300 lbs.(0-136 Kg) -Peak-hold needle automatically retains the highest reading until reset. -Handle easily adjusts to five grip position, from 1 3/8" -3 3/8", in half-inch increments. 5.2 Digital Pinch Gauge(SH5006) Unlike conventional pinch gauges, The SAEHAN Digital Pinch Gauge's unique design frees the client to perform a true pinch pattern because the therapist, not the client, supports the weight of the gauge. A highly accurate pinch-force measurement, devoid of artifact, is the result. Red indicator needle remains at maximum reading until reset. Measures pinch force to 601bs. includes instructions, handy carrying case.
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    K Number
    K042889
    Device Name
    DYNAMOMETER - MODEL FCE AND MODEL MSC
    Manufacturer
    AMETEK
    Date Cleared
    2004-11-16

    (28 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Chatillon FCE and MSC series dynamometers is for performing manual muscle testing to measure muscle strength. The target population for this product is individuals recovering from physical injury or for sports medicine applications.
    Device Description
    The Chatillon FCE and MSC series dynamometers are diagnostic devices used for evaluating muscle strength. These instruments are powered by a rechargeable battery (4.8 VDC) which supplied a regulated 2.5 VDC excitation voltage to a strain gauge load cell. The analog output from the load cell (2 mV/V) is then converted to a digital signal that is directly proportional to the applied force. This digital signal is then sent to a microprocessor, which converts the signal to a force value that is stored in memory and/or displayed on the dynamometer graphical display. This design has been used for many years in industrial force measuring instruments and has been also used for physical therapy, occupational medicine and sports medicine. These medical dynamometers are a repackaged version of the industrial force measurement instruments and are designed with special medical attachments that are appropriate for performing manual muscle testing and ergonomic analysis.
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    K Number
    K012492
    Device Name
    KADANCE 2000
    Manufacturer
    KADA RESEARCH, INC.
    Date Cleared
    2001-11-02

    (91 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease of his/her hand(s). To measure grip or pinch strength in an injured and uninjured hand. To conduct pre-employment screening for physically demanding job activities. To establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace.
    Device Description
    The KaDance 2000 system is designed to aid in the identification of fine motor performance issues, (median nerve entrapment), which may be present in either or both hands of a human. The system is non-invasive. This is accomplished by measuring how the thumb (digit 1), index finger (digit 2) and little finger (digit 5) maintain a grip throughout several repetitive exercisers. The applied forces exerted by the digits measured as a function of time. Measurements may be made as rapidly as once every 2 ms for all three digits simultaneously. The system consists of 1) hand sensor, 2) a data control module and laptop computer, 3) KaDaLink™ computer with KaDance 2000 software running. Data is displayed as force over time.
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    K Number
    K981730
    Device Name
    DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
    Manufacturer
    NK BIOTECHNICAL CORP.
    Date Cleared
    1998-07-17

    (63 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ULTIMATE System is indicated for use as follows: 1. to measure grip or pinch strength in an injured and uninjured hand. 2. to follow an injury through the rehabilitation process and measure progress or lack of progress, in terms of grip or pinch strength, of the therapy regimen or medical treatment. 3. to document baseline grip or pinch strength of the hands and lifting, pulling and pushing strength capabilities of employees and to monitor the strength of employees in the workplace over time. 4. generally, in any situation where the hand grip or pinch strength would be a valuable piece of data in the evaluation of a person who has sustained an injury or suffers a disease to his/her hand(s). 5. to establish an industrial strength testing program in general, and to match the strength of workers to the strength demands of specific job duties in the workplace (lifting, pulling and pushing protocols) in a simulated test. 6. to conduct pre-employment screening for physically demanding job activities.
    Device Description
    Not Found
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    K Number
    K980363
    Device Name
    ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)
    Manufacturer
    OROFACIAL DYNAMICS
    Date Cleared
    1998-04-16

    (77 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oro-Facial Myographic Measurement Instrument is intended as a diagnostic aid for the quantitative evaluation of oro-facial muscle strength. It is indicated for use in the oro-facial cavity.
    Device Description
    The Oro-Facial Myographic Measurement Instrument (OMMI™) is a myographic measurement method for direct strength measurement of the oro-facial muscles.
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    K Number
    K964933
    Device Name
    MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
    Manufacturer
    MEKANIKA, INC.
    Date Cleared
    1997-02-03

    (55 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K964685
    Device Name
    DYNAMOMETER
    Manufacturer
    JOHN CHATILLON & SONS, INC.
    Date Cleared
    1997-01-27

    (66 days)

    Product Code
    LBB
    Regulation Number
    888.1240
    Why did this record match?
    Product Code :

    LBB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength.
    Device Description
    The Chatillon CSD Series Dynamometers are diagnostic devices used for quantitatively evaluating muscle strength. These instruments are powered by a rechargeable battery (7.5 Vdc) which supplies a regulated 5 Vdc excitation voltage to a strain gage load cell. The output from the load cell passes through an A/D converter which produces a digital signal that is directly proportional to the applied force. This signal is then sent to a microprocessor which converts the signal to a force value that is stored in memory and/or displayed on an LCD. This basic design has been used for many years in industrial force measuring instruments that have found their way into hospitals, clinics and other similar facilities through industrial distributors. The instrument submitted herewith is a repackaged version of the industrial instrument with attachments that are more appropriate for performing manual muscle testing.
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