Search Filters

Search Results

Found 217 results

510(k) Data Aggregation

    K Number
    K243856
    Device Name
    TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026)
    Manufacturer
    Shenzhen AsTec Technology Co., Ltd.
    Date Cleared
    2025-05-29

    (164 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Not Found
    Ask a Question
    K Number
    K250360
    Device Name
    TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026)
    Manufacturer
    Shenzhen Jiantuo Electronics Co., Ltd.
    Date Cleared
    2025-05-11

    (90 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    Not Found
    Ask a Question
    K Number
    K250053
    Device Name
    TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
    Manufacturer
    Shenzhen Jiantuo Electronics Co., Ltd.
    Date Cleared
    2025-05-09

    (119 days)

    Product Code
    NUH, NGX
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS (Transcutaneous Electric Nerve Stimulation): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. EMS (Electrical Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
    Device Description
    TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)
    Ask a Question
    K Number
    K243613
    Device Name
    Patch-TEA (Model TRI-21)
    Manufacturer
    Transtimulation Research, Inc
    Date Cleared
    2025-04-09

    (138 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Patch-TEA is an Over-The-Counter device to be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
    Device Description
    The Patch-TEA device is a non-invasive, battery-operated, over-the-counter transcutaneous electrical nerve field stimulator indicated for use in adult patients for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use. The system includes the following components: Patch-TEA device, charging case, electrode pads, USB charging cable, and Patch-TEA app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The Patch-TEA device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The Patch-TEA device is able to connect with the Patch-TEA app, which is located on a smartphone. The user interface is available on both the Patch-TEA device and Patch-TEA app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the Patch-TEA device and Patch-TEA app located on a smartphone.
    Ask a Question
    K Number
    K250033
    Device Name
    Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E)
    Manufacturer
    Guangzhou Pinzhi Medical Technology Co., LTD
    Date Cleared
    2025-04-07

    (90 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PZ-2622 is TENS and EMS Stimulator Mode 1-12: TENS: This mode is designed 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. Mode 13-24: EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622E (Mode 1-24) is EMS Stimulator This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance. PZ-2622T (Mode 1-24) is TENS Stimulator This device is designed 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.
    Device Description
    Not Found
    Ask a Question
    K Number
    K242460
    Device Name
    Progenix Select Stim
    Manufacturer
    Progenix LLC
    Date Cleared
    2025-04-02

    (226 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
    Device Description
    The Progenix Select Stim (Model: PRO1205-OTC1) device is a portable, battery powered (9 V battery) two channel device designed to provide Transcutaneous Electrical Nerve Stimulation (TENS) for the purpose of the symptomatic relief of pain. The device consists of the TENS stimulator, two lead wires and set of four Skin Electrodes. It provides 10 preset TENS treatment programmes. The programs include four modes of operation: Conventional TENS(Continuous), Burst Mode, Modulation mode and HAN TENS. The device LCD screen shows the information of program, intensity level of each channel and operating time. The electrode pads are cleared by FDA (510(k) number K160138). They are used as an accessory to the TENS device unit, to transmit electrical current to patient skin. The electrodes consist of biocompatible self-adhesive conductive application use. These electrodes are sized 50x50mm and are sold under the model number PRO5050.
    Ask a Question
    K Number
    K242815
    Device Name
    POCKET TENS (EP-300)
    Manufacturer
    HIVOX BIOTEK INC.
    Date Cleared
    2024-12-17

    (90 days)

    Product Code
    NUH
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
    Device Description
    This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions. TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime. This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.
    Ask a Question
    K Number
    K243334
    Device Name
    Nooro Body & Foot Stimulator (SM9141, SM9142)
    Manufacturer
    XF Agencija Limited
    Date Cleared
    2024-11-22

    (29 days)

    Product Code
    NUH, GZJ, IPF, NGX, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-The-Counter Use: TENS: The device (SM9141, SM9142) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities and also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. EMS/NMES: The device (SM9141, SM9142) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, feet and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. The device (SM9141, SM9142) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities. For Prescription Use: Device (SM9141, SM9142): TENS: - Symptomatic relief and management of chronic, intractable pain - Adjunctive treatment for post-surgical and post-trauma acute pain - Relief of pain associated with arthritis EMS/NMES: - Temporary relaxation of muscle spasm - Prevention or retardation of disuse atrophy - Muscle re-education - Maintaining or increasing range of motion - Increase of local blood flow in the treatment area - Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
    Device Description
    Not Found
    Ask a Question
    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?
    Product Code :

    NUH

    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
    Not Found
    Ask a Question
    K Number
    K242567
    Device Name
    Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C)
    Manufacturer
    Changsha Anxiang Medical Technology Co., Ltd.
    Date Cleared
    2024-11-04

    (67 days)

    Product Code
    NUH, NGX
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    NUH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 22