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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    SAEHAN CORP.

    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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