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510(k) Data Aggregation

    K Number
    K191547
    Device Name
    ReliefBand
    Date Cleared
    2019-08-30

    (79 days)

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

    ReliefBand Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ReliefBand(R) is indicated for use in the treatment of nausea, vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. ReliefBand is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.
    Device Description
    ReliefBand® models 1.5 and 2.0 are battery-powered non-invasive digital therapeutic devices that are worn on the wrist like a watch. They are indicated for the counter use in the relief of mild to moderate nausea and retching associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness associated with pregnancy as an adjunct to antiemetics in reducing mild to moderate postoperative nausea. ReliefBand 1.5 and 2.0 include two electrical contacts on the back of the device (ReliefBand 1.5) or on the clasp (ReliefBand 2.0), which must be placed firmly against the underside of the wrist at the P6 location (approximately two fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles). The electrodes provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist. The ReliefBand device has a user display that includes a five-level (ReliefBand 1.5) or 10-level (ReliefBand 2.0) LED that indicates the signal intensity. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton located on the face of the devices. A low battery indicator LED is also included on the face of the devices. ReliefBand 1.5 uses disposable batteries while ReliefBand 2.0 has a lithium-ion rechargeable battery. A fully charged battery will last for up to 18 hours of continuous use at the mid-power level or below.
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    K Number
    K182960
    Device Name
    ReliefBand
    Date Cleared
    2019-06-21

    (239 days)

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

    ReliefBand Technologies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ReliefBand 2.0 is indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, chemotherapy and morning sickness associated with pregnancy. ReliefBand 2.0 is also indicated as an adjunct to antiemetics in reducing postoperative nausea.
    Device Description
    ReliefBand® 2.0 is a rechargeable, non-invasive digital therapeutic device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over the counter use in the relief of mild to moderate nausea and vomiting associated with chemotherapy, motion sickness, mild to moderate nausea and vomiting associated with pregnancy, and as an adjunct to antiemetics in reducing mild to moderate postoperative nausea. ReliefBand 2.0® includes a hypoallergenic band with two electrical contacts on the clasp end of the band. The two contacts must be placed firmly against the underside of the P6 location, approximately two fingers breadth above the distal skin crease of the wrist joint, between the tendons of the palmaris longus and flexor carpi radialis muscles. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist. The ReliefBand® Device has a user display that incorporates a ten-segment linear LED that is used to display the intensity level. The patient can easily select the pulse amplitude of the electrical impulse and control the intensity of the stimulation via a pushbutton located on the edge of the device. Battery charge level is indicated by a separate four-segment circular LED. A fully charged battery will last for approximately 18 hours of continuous use at the mid-power level or below.
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    K Number
    K173233
    Device Name
    ReliefBand 1.5
    Date Cleared
    2017-11-30

    (56 days)

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

    ReliefBand Technologies

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Reliefband® is a digital therapeutic device indicated for use in the treatment of nausea, retching and vomiting due to motion sickness, morning sickness associated with pregnancy, and chemotherapy. Reliefband® is also indicated as an adjunct to antiemetic therapy in reducing postoperative nausea.
    Device Description
    The ReliefBand® 1.5 is a non-invasive device that is indicated for the counter use in the relief of mild to moderate nausea, retching and vomiting associated with chemotherapy, motion sickness, mild to moderate nausea and vomiting associated with pregnancy, and as an adjunct to antiemetics in reducing mild to moderate postoperative nausea. This device was originally marketed under its predicate name of Reliefband RB-EL (K020180) when owned by Woodside Biomedical, Inc. The devices are technologically identical. The same contract manufacturer has made this device for decades. Exactly like its predicate, the Reliefband 1.5 is contained within a wristband, and provides relief of nausea, retching and vomiting through electrical stimulation of the nerves on the ventral side of the patient's wrist. The device can be worn on the ventral or palmar (i.e., inside) surface of either or both wrists, approximately two 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® 1.5 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.
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