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510(k) Data Aggregation

    K Number
    K060975
    Device Name
    IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
    Manufacturer
    THERATECH, INC.
    Date Cleared
    2006-05-10

    (30 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
    Device Description
    The WL-2206A1 and WL-2206A2 are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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    K Number
    K050847
    Device Name
    IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
    Manufacturer
    THERATECH, INC.
    Date Cleared
    2005-06-17

    (74 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
    Device Description
    The WL-2206A is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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    K Number
    K024100
    Device Name
    IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
    Manufacturer
    THERATECH, INC.
    Date Cleared
    2003-02-25

    (75 days)

    Product Code
    LIH
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
    Device Description
    The WL-2206 is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
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    K Number
    K021436
    Device Name
    TTECH MODEL 200E + TENS DEVICE
    Manufacturer
    THERATECH, INC.
    Date Cleared
    2002-07-30

    (85 days)

    Product Code
    GZJ
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.
    Device Description
    The Ttech 200E + TENS Device is a battery-operated device that includes controllable output channels. This TENS device creates electrical impulses whose intensity, duration, number per second and modulation can be altered with the controls and switches. There are two separate amplitude controls (channels). Every channel can be connected with the lead wire, on which two pieces of electrodes are to be connected to the end of the wire to provide stimulation for the intended part of the body. There are three operation modes: - . Convention Mode (c) - Burst Mode (b) - Modulated Mode (c) . The operator may choose any one of them, as applicable. The device includes the following: - 1 TENS Unit . - . 2 Leads - 1 9v Battery ● - 1 Operation Manual . - 1 Carrying Case .
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    K Number
    K013768
    Device Name
    POWERED MUSCLE STIMULATOR
    Manufacturer
    THERATECH, INC.
    Date Cleared
    2002-07-03

    (232 days)

    Product Code
    IPF
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERATECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    As an NMES device, the Ttech NMES is indicated for the following conditions: - Relaxation of muscle spasms . - . Prevention or retardation of disuse atrophy - Increasing local blood circulation . - . Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent . venous thrombosis; and - t Maintaining or increasing range of motion
    Device Description
    The Ttech NMES is a dual channel NMES device that produces a mild electrical current that is transmitted via leads to electrodes placed on the skin in areas predetermined by the clinician. The device, a set of electrodes with their lead wires, a battery (9 volt), carrying case, and instructions for use make up the Ttech NMES system.
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