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510(k) Data Aggregation

    K Number
    K250286
    Device Name
    Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
    Manufacturer
    The Magstim Company Limited
    Date Cleared
    2025-07-03

    (153 days)

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

    QPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K241785
    Device Name
    StarFormer (M008-3T)
    Manufacturer
    Fotona d.o.o.
    Date Cleared
    2025-03-27

    (280 days)

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

    QPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    With handheld applicators: PMS mode: Fotona StarFormer is intended for muscle conditioning, used for stimulating muscles including abdomen muscles in order to improve or facilitate muscle performance. Fotona StarFormer is intended to be used under medical supervision for adjunctive therapy. Fotona StarFormer is intended for stimulating neuromuscular tissue for bulk muscle excitation in arms, legs, buttocks and thighs for rehabilitative purposes - Prevention of disuse atrophy and increasing local blood circulation. TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. With Chair Back applicator: TENS mode: Fotona StarFormer is intended to stimulate peripheral nerves in the back for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older. Fotona StarFormer is to be used for the temporary relief of pain associated with sore or aching muscles in the back due to strain from exercise or normal household work activities.
    Device Description
    StarFormer is a non-invasive therapeutic device. The device comprises of a magnetic stimulation coil located in the handheld applicators and in the back of a chair. During the treatment, an alternating electric current is sent into the stimulation coil. The coil builds up a rapidly changing magnetic waves which propagate into the underlying tissue where they induce a secondary electric current. This current stimulates neurons and activates muscle contractions. The device consists of a system controller board which also drives the touchscreen and the GUI, a high voltage current power supply, handheld applicators and a chair.
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    K Number
    K233364
    Device Name
    Axon Therapy
    Manufacturer
    NeuraLace Medical Inc.
    Date Cleared
    2024-01-10

    (100 days)

    Product Code
    QPL, IPF
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    QPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The Axon Therapy is for use on patients 18 and older.
    Device Description
    The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.
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    K Number
    K230014
    Device Name
    MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
    Manufacturer
    Tonica Elektronik A/S
    Date Cleared
    2023-08-25

    (234 days)

    Product Code
    QPL, OPL
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    QPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older
    Device Description
    The MagVenture Pain Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic and post-surgical pain. The subject device is intended to be used in hospitals and clinics such as pain management clinics. The device consists of Magnetic Stimulator, Stimulation Coils, Liquid Cool Unit (optional), and a Trolley. All coils of the MagVenture Pain Therapy have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the skin of the patient or operator. The temperature allowed by the system is maximum 43°C or between 44°C for less than 10 minutes. The system will automatically disable if this maximum temperature is reached.
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    K Number
    K210021
    Device Name
    Axon Therapy
    Manufacturer
    NeuraLace Medical, Inc.
    Date Cleared
    2021-06-11

    (158 days)

    Product Code
    QPL, IPF
    Regulation Number
    882.5890
    Why did this record match?
    Product Code :

    QPL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axon Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and postsurgical pain for patients 18 and older.
    Device Description
    The Axon Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide chronic nerve pain relief. The subject device is intended to be used in clinics such as pain management clinics and physical therapy clinics. The device consists of Magnetic Stimulation Coil, Liquid Cool Unit, and a Cart. The Axon Therapy includes a thermal shutdown feature which is activated once the inside temperature of the stimulation coil either: (A) reaches 45°C or (B) exceeds 41°C for a total of nine minutes during a 20-minute session.
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