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510(k) Data Aggregation

    K Number
    K210938
    Device Name
    PowerDot PD-01MT2 Muscle Stimulator
    Manufacturer
    Smartmissimo Technologies Pte Ltd
    Date Cleared
    2021-07-30

    (123 days)

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

    Smartmissimo Technologies Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PowerDot PD-01M2 is NMES/TENS stimulator with the following Over-The-Count indications for use: NMES - Stimulation of healthy muscles in order to improve or facilitate muscle performance TENS - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities When prescribed by healthcare provider, in addition, PowerDot PD-01M2 Muscle Stimulator can be also used with the following additional Rx only indications for use: NMES - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgerv TENS - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain
    Device Description
    PowerDot PD-01M2 Muscle Stimulator (with PowerDot Mobile Application)
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    K Number
    K210269
    Device Name
    PowerDot PD-01MT2 Muscle Stimulator
    Manufacturer
    Smartmissimo Technologies Pte Ltd
    Date Cleared
    2021-02-23

    (22 days)

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

    Smartmissimo Technologies Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerDot PD-01MT2 is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application). PowerDot PD-01MT2 has the following indications for use: NMES - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery - Stimulation of healthy muscles in order to improve or facilitate muscle performance TENS - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
    Device Description
    Not Found
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    K Number
    K181759
    Device Name
    PowerDot PD-01MT
    Manufacturer
    Smartmissimo Technologies Pte Ltd
    Date Cleared
    2018-11-09

    (130 days)

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

    Smartmissimo Technologies Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PowerDot PD-01MT stimulator is a prescription device which is intended to be used following the directions of a healthcare provider. The device can be either used by the therapist in healthcare facility setting (when operated from PowerDot Doctor Mobile Application) or by patient/lay operator in a home environment (when operated from PowerDot Patient Mobile Application). PowerDot PD-01MT has the following indications for use: NMES - Retarding or preventing disuse atrophy - Maintaining or increasing range of motion - Re-educating muscles - Relaxation of muscle spasms - Increasing local blood circulation - Prevention of venous thrombosis of the calf muscles immediately after surgery - Stimulation of healthy muscles in order to improve or facilitate muscle performance TENS - Symptomatic relief and management of chronic, intractable pain - Post-surgical and post-trauma acute pain - Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
    Device Description
    Not Found
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    K Number
    K172876
    Device Name
    PowerDot PD-01M
    Manufacturer
    Smartmissimo Technologies Pte Ltd
    Date Cleared
    2017-12-04

    (74 days)

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

    Smartmissimo Technologies Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PowerDot PD-01M device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. PowerDot PD-01M device and PowerDot Mobile Application is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
    Device Description
    PowerDot PD-01M device, used with PowerDot Mobile Application
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    K Number
    K150078
    Device Name
    PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
    Manufacturer
    Smartmissimo Technologies Pte Ltd
    Date Cleared
    2015-09-30

    (258 days)

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

    Smartmissimo Technologies Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
    Device Description
    PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training. PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application. PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application. Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.
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