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    K Number
    K242332
    Device Name
    Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494)
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd.
    Date Cleared
    2024-11-05

    (90 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electronic Nerve Stimulator is indicated 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. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.
    Device Description
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    K Number
    K232517
    Device Name
    Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412)
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd.
    Date Cleared
    2023-12-08

    (112 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: 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. For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with overthe-counter pain medications. It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
    Device Description
    Not Found
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    K Number
    K222870
    Device Name
    Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2023-05-10

    (230 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: - for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping - to temporarily increase local blood circulation in healthy leg muscles - to stimulate healthy muscles in order to improve and facilitate muscle performance - to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties - to relax muscle spasm - to increase blood flow circulation - for prevention of retardation of disuse atrophy - for muscle re-education - for maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Provide quadricep strengthening - Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: - symptomatic relief and management of chronic, intractable pain - relief of pain associated with arthritis - temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
    Device Description
    Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed models KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 provide a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands, mode 1-9 is for foot stimulation and mode body is for body stimulation; 2) wonderful electric pulse combination, 0~20 levels can be adjusted and chosen according to personal preference; 3) wireless remote control allows easy control of the device 5) use while seated or reclining; 6) LCD display makes the operation simple and easy. Transcutaneous Electrical Nerve Stimulator is mainly composed of the main unit, remote control and electrode pads.
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    K Number
    K220998
    Device Name
    Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd.
    Date Cleared
    2022-08-24

    (142 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: - for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping - to temporarily increase local blood circulation in healthy leg muscles - to stimulate healthy muscles in order to improve and facilitate muscle performance - to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties - to relax muscle spasm - to increase blood flow circulation - for prevention of retardation of disuse atrophy - for muscle re-education - for maintaining or increasing range of motion - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Provide quadricep strengthening - Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: - symptomatic relief and management of chronic, intractable pain - relief of pain associated with arthritis - temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
    Device Description
    Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed model KTR-405 provides a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands. Modes 1-8 are for foot and can be switched to another mode for a minute automatically, while mode 9 is for knee and mode 10 for body. Modes for foot, knee and body can be switched manually during a session; 2) wonderful electric pulse combination, 0~150 levels can be adjusted and chosen according to personal preference; 3) rechargeable battery which can work up to 36 hours 4) wireless and rechargeable remote control allows easy control of the device 5) use while seated or reclining with Relax and Recline mode; 6)foot cover helps keep feet warm and cosy; 7) LCD display and power display make the operation simple and easy; 8) carry handle for easy transportation; 9) magnetic power cable for simple and safe connection. Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it can be run either from the mains power supply or via its internal rechargeable battery. To start therapy, you need to connect the device to the mains power supply. This will charge the battery, allowing you to use the device wirelessly in subsequent sessions. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.
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    K Number
    K200177
    Device Name
    Low-frequency Multi-function physiotherapy instrument
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2021-03-25

    (426 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650:(TENS, EMS, FITNESS) TENS (Mode~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41~50): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen. KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (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.
    Device Description
    The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 1~20) is 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. EMS (Mode 21~40) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode. The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. 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
    K200237
    Device Name
    Transcutaneous Electronic Nerve Stimulator
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2020-10-19

    (269 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transcutaneous Electronic Nerve Stimulator is indicated 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.
    Device Description
    Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes: For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time. The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button. The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series). 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
    K191982
    Device Name
    Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212)
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2020-09-25

    (428 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS) TENS (Mode1~20): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (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.
    Device Description
    Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities. Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage. The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode. The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person. 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
    K183288
    Device Name
    Transcutaneous Electrical Nerve Stimulator
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2019-07-30

    (246 days)

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

    Shenzhen Kentro Medical Electronics 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, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
    Device Description
    Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use. The Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.
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    K Number
    K181728
    Device Name
    Muscle Trainer
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2018-10-17

    (110 days)

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

    Shenzhen Kentro Medical Electronics Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Muscle Trainer is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes. Muscle Trainer is mainly composed of the host and electrode patches, as well as it is powered by CR2023 battery. Of which, the electrode patch is cleared in K171381. Muscle Trainer includes KTR-230 series (KTR-230B, KTR-230W, KTR-230P), KTR-231, KTR-232, KTR-233 and KTR-234 model. All models have three operation modes and one channel, which can give certain electrical pulse through electrode patches on the skin. Their technical parameters are slightly different, but they share the basically same characteristics: - Electric pulse combination, 0~12 levels can be adjusted and chosen according to personal preference. - CR2032 Button batteries (DC3V) power supply, easy to use and safe. The main differences among them are the followings but not affect its intended use: - Appearance - The number of control button: KTR-230 series, KTR-231 and KTR-232 have two buttons to control: KTR-233 and KTR-234 have three buttons to control. - The number of electrode patch used: KTR-230 series, KTR-233 and KTR-234 are equipped with one electrode patch; KTR-231 is equipped with six electrode patches as well as KTR-232 is equipped with two electrode patches. - Applied parts: KTR-230 series, KTR-233 and KTR-234 apply to abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.
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    K Number
    K170205
    Device Name
    Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203
    Manufacturer
    Shenzhen Kentro Medical Electronics Co., Ltd
    Date Cleared
    2017-05-11

    (108 days)

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

    Shenzhen Kentro Medical Electronics 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, arm, leg and foot, due to strain from exercise or normal household and work activities
    Device Description
    The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim. There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment. The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.
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