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510(k) Data Aggregation

    K Number
    K212989
    Device Name
    Low-frequency Stimulator (Model: AST-645, AST-646)
    Manufacturer
    Shenzhen OSTO Technology Co., Ltd.
    Date Cleared
    2021-11-22

    (63 days)

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

    Shenzhen OSTO Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. PMS: It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. Heating: It is intended for temporary relief of minor aches and pains.
    Device Description
    The Low-frequency stimulator is a portable device. It has 10 modes: 9 stimulation modes each has 99 levels of intensity and 1 heating mode has 3 levels of heating intensity, which can give certain stimulation to help the users relax their muscle and relief their pain. The Low-frequency stimulator has 7 buttons on the main unit: Press Power button to turn on/off the device. Press "Mode+" and "Mode-" buttons to select 9 stimulation modes; Press "Intensity+" and "Intensity-" to increase or decrease the stimulus intensity, there are a total of 99 intensities to choose from; Press "Heat" to adjust the heating temperature, there are three temperatures(38℃, 40℃ and 43℃) that can be adjusted. Press "Time" to adjust the treatment time, increasing by five minutes each time, up to 60 minutes. It will automatically shut down in 30 minutes by default when it is turned on. The LCD screen can show stimulation intensity, heating intensity, heating intensity and time remaining of an application mode. All the functions of the device can only be controlled by the button on the main unit. The device is equipped with an adapter, bandage, a pair of electrode wire. The electrode wire is used to connect the electrode pads to the main unit. There are four conductive heads on the main unit, which are mainly composed of stainless steel sheets and giving users stimulation and heating functions, and help users relieve knee pain. The stimulation and heating functions can happen simultaneously or independently by control the button on the main unit. When in use, the main unit is fixed with a bandage, and the electrode sheet is placed at the relevant treatment site according to the instructions. The electrode pads can be used on the guidance site for stimulation only when connected to the host. There are two models of the device, which differ only in appearance. The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.
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    K Number
    K182136
    Device Name
    Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
    Manufacturer
    Shenzhen OSTO Technology Co., Ltd.
    Date Cleared
    2019-10-10

    (430 days)

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

    Shenzhen OSTO Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.
    Device Description
    Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs. The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device. There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment. The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.
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    K Number
    K172897
    Device Name
    Neck Care Therapy, Model: SYK 509B
    Manufacturer
    Shenzhen OSTO Technology Co., Ltd.
    Date Cleared
    2018-12-07

    (441 days)

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

    Shenzhen OSTO Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities. - Neck Pad is used in back of neck. - Meridian Pad is used in shoulder, waist, back, and arm.
    Device Description
    This instrument is a new generation of household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low frequency electrotherapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg. The Neck Pad is used in for back of neck and it accord with human body cervical physiological curvature of streamlined ring design accord with human body cervical physiological curvature of streamlined ring design. The Meridian Pad is used in shoulder, waist, back, and arm. The device has one operation modes which has 2 modes and 50 output Intensity Level, so the device can give certain electrical pulse through 2 pairs of electrode pads or the Neck Pad on the skin to help users to enjoy body massage and sole massage. The remote control of this device is user-friendly controlled because it has the operating elements of ON/OFF knob, left or right button and increase or decrease button. The device is equipped with accessories of electrode pads and an electrode wire is used to connect the pads to the main unit. The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode. The device can be successfully opened only when switch button of the remote control and Neck Pad turned on at the same time. The remote control is the only controller to select the pulse intensity and adjust the treatment time.
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    K Number
    K172837
    Device Name
    Low-frequency Multi-function physiotherapy instrument
    Manufacturer
    Shenzhen OSTO Technology Co., Ltd.
    Date Cleared
    2018-11-26

    (433 days)

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

    Shenzhen OSTO Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
    Device Description
    Physiotherapy instrument has 2 operation modes and one channel, after insert the electrode wire of the electrode pads, just put the electrode pads on the same side of your body, for shoulder, waist, back, back of the neck, arm, leg or foot (depends on your need, please consult your doctor before using if need), which can give certain electrical pulse through 2 pieces of electrode pads on the skin. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity enhancement/weakening keys, language switch button and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, time remaining of an application mode, language display systemy. The device is equipped with accessories of electrode pads, electrode wire, adapter. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
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    K Number
    K172834
    Device Name
    Dual output digital therapy massager
    Manufacturer
    Shenzhen OSTO Technology Co., Ltd.
    Date Cleared
    2018-09-06

    (352 days)

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

    Shenzhen OSTO Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PMS (Mode 1) It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS (Mode 2) To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
    Device Description
    Low-frequency Multi-function Physiotherapy Instrument is a household multifunctional device. it can stimulate healthy muscles in order to improve and facilitate muscle performance, and to relief the pain associated with sore and aching muscles in the waist, upper and lower back, back of the neck, upper extremities (shoulder, arm and hand), lower extremities (hip, knee, ankle, leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. Low-frequency Multi-function Physiotherapy Instrument has 2 operation modes and two channels, which can give certain electrical pulse through 2 pairs of electrode pads on the skin to help users to enjoy body massage and sole massage. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys and time selection keys. The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.
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