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510(k) Data Aggregation

    K Number
    K220283
    Device Name
    TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033)
    Manufacturer
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Date Cleared
    2022-05-02

    (90 days)

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

    Hong Qiangxing (Shen Zhen) Electronics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SM9009: TENS(1-7,9,10,14,16,19,21,22,24): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(8,11,12,13,15,17,18,20,23): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9021: TENS(3-6,8-11,15,16,19,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,2,7,12,13,14,17,18,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9128H: TENS(2-6,9,11,14,16,19,21,22,24): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,7,8,10,12,13,15,17,18,20,23): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9015: TENS(2-4.8.9.10.12.13.14.15.17.18.19.20.22): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1.5,6.7,11,16,21,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9055: TENS(1-8,10,11,13,14,16,19,21-25,30,31,35,36): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(9,12,15,17,18,20,26,27,28,29,32,33,34): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9033: TENS(1-16,19,21,22): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(17,18,20,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
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    K Number
    K220152
    Device Name
    TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555)
    Manufacturer
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Date Cleared
    2022-04-19

    (90 days)

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

    Hong Qiangxing (Shen Zhen) Electronics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SM9089: TENS(3,4,5,6,8,15,19,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,2,7,9,10,11,12,13,14,16,17,18,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9587: TENS(3.4.5.6 8.11.15.16.19.21.22): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,2,7,9,10,12,13,14,17,18,20,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9592: TENS(2,3,4,5,7,9,10,19,21,22,24): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,6,8,11,12,13,14,15,16,17,18,20,23): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. SM9555: TENS(3-6, 13,14,19-21,23): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,2,7-12,15-18,22,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
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    K Number
    K220150
    Device Name
    TENS & PMS (Model: SM9126)
    Manufacturer
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Date Cleared
    2022-02-17

    (29 days)

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

    Hong Qiangxing (Shen Zhen) Electronics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS (3-6, 13, 14, 20, 21, 23): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (1, 2, 7-12, 15-19, 22, 24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
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    K Number
    K201354
    Device Name
    TENS & PMS
    Manufacturer
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Date Cleared
    2020-12-11

    (204 days)

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

    Hong Qiangxing (Shen Zhen) Electronics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS(1,3,4,5,6,21): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(2,7,8,9,10,11,12,13,14,15,16,17,18,19,20,22,23,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Model: SM9126 TENS(3,4,5,6,11,12,16): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,2,7,8,9,10,13,14,15): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Model: SM9186 TENS(3,4,7,8,11): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1,2,5,6,9,10,12): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Model: SM9196 TENS(10~15): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(1~9): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    TENS & PMS is a portable and DC 3.7V battery powered multifunction device with multiple models, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.
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    K Number
    K190009
    Device Name
    Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S)
    Manufacturer
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Date Cleared
    2019-12-02

    (333 days)

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

    Hong Qiangxing (Shen Zhen) Electronics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Model SM9187: TENS (Mode 1, 3, 4, 5, 6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Model SM9180L & SM9180S: TENS (Mode 1. 3. 4. 5. 6): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back due to strain from exercise or normal household work activities. PMS (Mode 1, 2, 3, 4, 5, 6): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Sunmas TENS & PMS (Model SM9187, SM9180L & SM9180S) is a portable battery powered device with a wireless feature for over-the-counter use, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device. Sunmas TENS & PMS has totally 6 modes, applying electrical current to electrodes on a patient's skin to relieve pain or build up muscle. Due to different electrode shapes and sizes, Model SM9187 can be used on the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (legs), while Model SM9180L and SM9180S can be used on the shoulder, back and abdomen. Model SM9187 is designed to be controlled by a mobile phone application program (APP) named “Dr.Stim”, through Bluetooth 4.0 technology (Frequency: 2402.0 - 2480.0MHz). The APP is developed by Hong Qiangxing (Shenzhen) electronics Limited. SM9187 consists of a round main unit, two sets of self-adhesive electrode pad, a mobile application (APP), an AC charger and a USB cable. Model SM9180L and SM9180S both have a butterfly-shaped main unit (Frequency: 2450MHz) and can be remotely controlled through wireless technology. SM9180L has a black remote control with an electronic display screen which is powered by two AAA alkaline batteries, while Model SM9180S has a white remote control powered by a CR2032 coin battery. The radio frequency of remote control (both black and white) is 2405.0 - 2470.0MHz. Model SM9180L and SM9180S consists of a unit, two pairs of electrode gels, a remote control (black or white), an AC charger and a USB cable.
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    K Number
    K183154
    Device Name
    SM Electrodes
    Manufacturer
    Hong Qiangxing (Shen Zhen) Electronics Limited
    Date Cleared
    2019-03-26

    (132 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    Hong Qiangxing (Shen Zhen) Electronics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SM Electrodes are intended to transmit electrical current to patient skin for use with transcutaneous electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use.
    Device Description
    SM Electrode pad is used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current of electrode pad is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin. SM Electrode Pad is composed of a top cover material, connector snap button, conductive carbon film, conductive hydrogel media, and a carrier line. It is non-sterile and intended for single adult patient multiple application use. The SM Electrode has various shapes and sizes. To connect with a nerve or muscle stimulator, this SM Electrode Pad has male snap button. The electrical pad connecting two separated gels together through a non-woven fabric has a pair of male snap button and the diameter is 3mm. The electrical pad with only one male snap button are to be used in pairs and the diameter of snap button is 4mm. When not in use, the hydrogel face is covered by a PET(polyethylene terephthalate) carrier line.
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    K Number
    K121719
    Device Name
    SM TENS & PMS
    Manufacturer
    HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
    Date Cleared
    2013-05-10

    (333 days)

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

    HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED

    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, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed by special person. The electrodes are interchangeable. The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.
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