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510(k) Data Aggregation

    K Number
    K020180
    Device Name
    RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    2002-03-21

    (62 days)

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

    WOODSIDE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReliefBand® device is indicated for use in the relief of nausea and vomiting due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy.
    Device Description
    The ReliefBand® Device Models RB-DL, RB-EL, and RB-RL are non-invasive devices which are indicated for over the counter use in the relief of nausea and vomiting (NV) due to motion sickness, and for the relief of mild to moderate nausea and vomiting associated with pregnancy. The devices are contained within a wristband, and provide relief through electrical stimulation of the nerves in the patient's wrist. The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately 2 fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles. The ReliefBand® device Model RB-xL family has a user display that incorporates five blinking LEDs which are used to identify the intensity level (5 discrete LEDs, one for each intensity level), so that the patient can easily select the desired stimulation. Selection of the intensity level is performed via a pushbutton located on the user display, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. A sixth blinking LED is used to display the low battery indicator. The ReliefBand® device Model RB-xL family is powered by two 3V lithium batteries. The batteries are not user replaceable in the disposable device model RB-DL, but are user replaceable in the reusable device models RB-EL and RB-RL. The battery life for all models is specified to be 150 hours when used at setting 3.
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    K Number
    K994387
    Device Name
    RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    2000-03-16

    (79 days)

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

    WOODSIDE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The ReliefBand® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).
    Device Description
    The ReliefBand® NST™ Device Models WB-2L, WB-6L, and WB-RL are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The ReliefBand ® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON). The devices are contained within a wristband, and provide relief of NV and PON through electrical stimulation of the nerves in the patient's wrist. The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately 2 fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles. The ReliefBand™ NST™ device Model WB-xL family has a user display that incorporates five blinking LEDs which are used to identify the intensity level (5 discrete LEDs, one for each intensity level), so that the patient can easily select the desired stimulation. Selection of the intensity level is performed via a pushbutton located on the user display, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. A sixth blinking LED is used to display the low battery indicator. The ReliefBand™ NST™ device Model WB-xL family is powered by two commercially available 3V lithium batteries. These batteries are not user replaceable in the disposable 2 day (WB-2L) and 6 day (WB-6L) devices, but are user replaceable in the Reusable device (WB-RL). The battery life for the 2 day device is specified to be 50 hours when used at setting 3. The battery life for the 6 day and Reusable devices is specified to be 150 hours when used at setting 3.
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    K Number
    K983907
    Device Name
    RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    1999-12-09

    (401 days)

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

    WOODSIDE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The ReliefBand® NST™ Device is indicated as an adjunct to antiemetics in reducing postoperative nausea (PON).
    Device Description
    ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R
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    K Number
    K982967
    Device Name
    RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    1999-02-23

    (182 days)

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

    WOODSIDE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReliefBand® Device is indicated for the relief of nausea and vomiting (NV) due to motion sickness
    Device Description
    ReliefBand® Device Models RB-2, RB-6, and RB-R
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    K Number
    K982436
    Device Name
    RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    1998-10-08

    (86 days)

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

    WOODSIDE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReliefBand® NST™ Device is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
    Device Description
    The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R are non-invasive nerve stimulation therapy devices, and are indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, pregnancy, and therapy related to acquired immune deficiency syndrome (AIDS). The devices are contained within a wristband, and provide relief of nausea and vomiting through electrical stimulation of the nerves in the patient's wrist. The devices can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists. approximately 2 fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles. The ReliefBand® NST™ Device Models WB-2, WB-6, and WB-R have a single dial for setting the stimulation , and incorporate an LED which is used to display a normal operating condition (green color at a slow flash rate) and a low battery condition (red color at a faster flash rate). All three models have a single operating mode, controlled by a single dial, which controls the peak pulse amplitude of the electrical impulse and thereby determines the intensity of the stimulation. The three models vary by (1) the number of intensity settings available to the user, (2) whether or not the device is reusable, and (3) the length of time that the batteries will last.
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    K Number
    K980333
    Device Name
    RELIEFBAND
    Manufacturer
    WOODSIDE BIOMEDICAL, INC.
    Date Cleared
    1998-02-18

    (21 days)

    Product Code
    GZJ, 73B
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    WOODSIDE BIOMEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ReliefBand is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
    Device Description
    The ReliefBand® Model SW-111 is a non-invasive nerve stimulation therapy device, and is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy. The device is contained within a wristband, and provides relief of NV through electrical stimulation of the P6 acupuncture area on the patient's wrist. This acustimulation wrist band can be worn on either hand on the ventral or palmar (i.e., inside) surface of the wrist, approximately 2-3 fingers breadth above the distal skin crease of the wrist joint between the tendons of the palmaris longus and flexor carpi radialis muscles. There are three operating modes based on pulse amplitude modulation scheme: - Mode A: 2 second burst, 6 seconds off. This is the first setting in the 3 mode sequence. - Mode B: 4 second burst. continuous. This is the second setting in the 3 mode sequence. - Mode C: 2 second burst, continuous. This is the third setting in the 3 mode sequence. There are six intensity levels present for each of the three operating modes, and the intensity setting determines the strength of the stimulation. The user display on the wristband identifies both the operating mode and intensity level, so the patient can select the desired stimulation. The wristband is powered by either three silver oxide batteries (type 392/IEC SR41, 1.5 V), or three zinc-air batteries (type 312/IEC PR41, 1.4V), and should not be immersed in water.
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