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510(k) Data Aggregation

    K Number
    K040679
    Device Name
    RICH-MAR AUTOPRISM INFRARED LAMP
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2004-05-07

    (53 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rich-Mar AutoPrism is an infrared lamp as classified under 21 CFR Part 890.5500. As such, it emits energy to provide topical heating for the temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness, and the relaxation of muscles; for muscle spasms, and for temporary relief of minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions
    Device Description
    Not Found
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    K Number
    K031018
    Device Name
    AUTOGEL PAD
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2003-12-08

    (252 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Conductive medium for transmission of therapeutic ultrasound to tissue.
    Device Description
    Not Found
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    K Number
    K032941
    Device Name
    AUTOSOUND 7.6 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2003-10-22

    (30 days)

    Product Code
    IPF, GZJ, IMG, IMI, LIH
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms: - 1. Relaxation of muscle spasms. - Prevention or retardation of disuse atrophy. 2. - 3. Increasing local blood circulation. - 4. Muscle re-education. - 5. Maintaining or increasing range of motion. - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. 6. Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms: - 1. Symptomatic relief of chronic intractable pain. - 2. Management of pain associated with post-traumatic or post operative conditions. Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: - 1. Relief of pain - 2. Muscle spasms - 3. Joint contractures But NOT for the treatment of malignancies
    Device Description
    Not Found
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    K Number
    K021483
    Device Name
    RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2002-09-13

    (128 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: - Relief of pain - Muscle spasms - Joint contractures But NOT for the treatment of malignancies
    Device Description
    Not Found
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    K Number
    K013770
    Device Name
    MODIFICATION TO: WINNER ST-2 STIMULATOR
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2002-01-18

    (66 days)

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

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms: - 1. Relaxation of muscle spasms. - 2. Prevention or retardation of disuse atrophy. - 3. Increasing local blood circulation. - 4. Muscle re-education. - 5. Maintaining or increasing range of motion. - 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms: - 1. Symptomatic relief of chronic intractable pain. - 2. Management of pain associated with post-traumatic or post operative conditions.
    Device Description
    Not Found
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    K Number
    K013771
    Device Name
    MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2002-01-18

    (66 days)

    Product Code
    IPF, GZJ, IMG, IMI, LIH
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Muscle stimulator indications for treatment using Quadpolar, Bipolar, Monophasic, and Russian waveforms: 1. Relaxation of muscle spasms. 2. Prevention or retardation of disuse atrophy. 3. Increasing local blood circulation. 4. Muscle re-education. 5. Maintaining or increasing range of motion. 6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Indications for treatment using Quadpolar Interferential and Microamperage Pulsed Current (Microcurrent) waveforms: 1. Symptomatic relief of chronic intractable pain. 2. Management of pain associated with post-traumatic or post operative conditions. Rich-Mar ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: 1. Relief of pain 2. Muscle spasms 3. Joint contractures But NOT for the treatment of malignancies
    Device Description
    Not Found
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    K Number
    K012848
    Device Name
    WINNER CM4 COMBINATION UNIT
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2001-10-25

    (63 days)

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

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THERAPEUTIC ULTRASOUND Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: 1) Relief of pain 2) Muscle Spasms 3) Joint contractures But NOT for the treatment of malignancies MICROAMPERAGE PULSED CURRENT INDICATIONS FOR TREATMENT (Microcurrent) Microcurrent output is indicated for the following conditions: 1) Symptomatic relief of chronic, intractable pain. 2) Management of pain associated with post-traumatic or post-operative conditions. Quadpolar, Bipolar, Monophasic and Russian Waveforms This device is indicated for the following conditions: 1) Relaxation of muscle spasms. 2) Prevention or retardation of disuse atrophy. 3) Increasing local blood circulation. 4) Muscle re-education. 5) Maintaining or increasing range of motion. 6) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. (Quadpolar Interferential and Microamperage Pulsed Current) 1) Symptomatic relief of chronic, intractable pain, 2) Management of pain associated with post-traumatic or post-operative conditions.
    Device Description
    Not Found
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    K Number
    K000808
    Device Name
    RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    2000-08-25

    (165 days)

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

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K982544
    Device Name
    RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
    Manufacturer
    RICH-MAR CORP.
    Date Cleared
    1998-11-19

    (121 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    RICH-MAR CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rich-Mar Ultrasound devices are indicated to produce therapeutic deep heat for the following conditions: - l) Relief of pain - 2) Muscle Spasms - 3) Joint contractures But NOT for the treatment of malignancies
    Device Description
    Rich-Mar US500, US750, US1000, Therapeutic Ultrasound Devices
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