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510(k) Data Aggregation

    K Number
    K221425
    Device Name
    Primary Relief
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2022-09-13

    (120 days)

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

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery or up to 3 days adjunctive symptomatic relief of post-operative pain following cardiac surgery.
    Device Description
    The Primary Relief is designed to aid in the reduction of post-operative pain by the method of cranial electrical stimulation at the auricular stimulation points. The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over three days / 72 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 72 hours. There stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K221231
    Device Name
    Drug Relief v1
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2022-06-06

    (38 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Applicant Name (Manufacturer) :

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
    Device Description
    The Drug Relief v1 is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 120 hours. There are three stimulation electrode and one ground electrode which constitute of a titanium needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. The device is rectangular in shape and designed to fit comfortably on the neck. The biocompatible adhesive ensures that the device maintains contact with the skin during normal use. The adhesive fasteners ensure that the electrode needles and the entire device stay in place in a secure manner. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing interpulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K220397
    Device Name
    ANSiStim-PP
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2022-05-12

    (90 days)

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

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K213188
    Device Name
    Primary Relief
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2022-01-31

    (124 days)

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

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Primary Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for up to 3 days for symptomatic relief of post-operative pain following cesarean section delivery.
    Device Description
    The Primary Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over 3 days / 72 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 72 hours. There are three stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K212859
    Device Name
    First Relief
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2021-12-20

    (103 days)

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

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The First Relief is a percutaneous electrical nerve stimulator (PENS) system indicated for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy.
    Device Description
    The First Relief is designed to aid in the treatment of chronic pain symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The First Relief is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over seven days / 168 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 168 hours. There stimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device.
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    K Number
    K211971
    Device Name
    Drug Relief v1
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2021-11-05

    (134 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Applicant Name (Manufacturer) :

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drug Relief v1 is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of cranial nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
    Device Description
    The Drug Relief v1 is designed to be used as an aid to reduce opioid withdrawal symptoms by the method of cranial electrical stimulation at the auricular stimulation points. The Drug Relief v1 is a wearable, battery-operated device that is designed to administer periodical low level electrical pulses to the ear over five days / 120 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of cranial Nerves on the ear through a set of wire assembly and stimulation needles. Three zinc air batteries with 1.4 V each provide the required stimulation energy for 120 hours. There atimulation electrode and one ground electrode which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals and a duty cycle of 2 hours ON/1 minute OFF. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K173861
    Device Name
    Drug Relief
    Manufacturer
    DyAnsys, Inc.
    Date Cleared
    2018-05-02

    (133 days)

    Product Code
    PZR
    Regulation Number
    882.5896
    Why did this record match?
    Applicant Name (Manufacturer) :

    DyAnsys, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Drug Relief is a percutaneous nerve field stimulatory (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX, and X, and the occipital nerves identified by transillumination.
    Device Description
    The Drug Relief™ is designed to aid in the treatment of opiate withdrawal symptoms by the method of electrical stimulation at the auricular stimulation points. The Drug Relief is a wearable, battery-operated device that is designed to administer periodical low-level electrical pulses to the ear over five days / 120 hours (2 hours ON/1 minute OFF) from the time of activation of the device. The electrical pulse from the device will be delivered to the branches of Cranial Nerves on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 120 hours. There are three Stimulation electrodes and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of rectangular pulses with differing inter-pulse intervals. A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.
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    K Number
    K141168
    Device Name
    ANSISTIM
    Manufacturer
    DYANSYS, INC.
    Date Cleared
    2015-05-15

    (374 days)

    Product Code
    BWK
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYANSYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ANSiStim™ is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
    Device Description
    The ANSiStim™ is a wearable battery-operated device that is designed to administer continuous low-level electrical pulses at the ear over four days. The stimulation needles are inserted at three specific points, which have the ability to stimulate the acupoints in the human body. Three zinc air batteries with 1.4 V provide the required stimulation energy for a maximum of 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation, stimulation is applied for 3 hours, followed by a pause of 3 hours.
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    K Number
    K091397
    Device Name
    ECSCOPE 200
    Manufacturer
    DYANSYS, INC.
    Date Cleared
    2009-07-08

    (57 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYANSYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ECScope 200 portable, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 200 will acquire and record 12 ECG leads simultaneously. The interpretation software is intended to support the physician in evaluating the ECG in terms of morphology and rhythm. Interpretation results must be overviewed and approved by trained physicians. Interpretation just represents partial qualitative and quantitative information of the general patient cardiovascular conditions. No therapy or drugs can be administered based solely on the interpretation statements. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.
    Device Description
    ECScope 200 is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module. ECScope 200 is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVF, V1, V2, V3, V4, V5 & V6, featuring alphanumeric display and keyboard. This product has an option to print ECG data through inbuilt 2 inch thermal printer or through external USB printer. The ECG data can also be transferred in image format to USB Key or to the computer through USB Cable. ECScope 200 can record and store in its database up to 30 ECGs. Each ECG record includes patient data, doctor's information and ECG measurements. Stored ECG can be printed directly on inbuilt Thermal Printer or through external USB printer. ECScope 200 has optional ECG interpretative software which gives statements and measurements that represents partial qualitative and quantitative information of the patient's general cardiovascular conditions. Interpretation program Hanover ECG System (HES) providing the following additional information: - Representatives templates of each lead including markers on fiducial points . - . Summary of mean measurements - Summary of measurements performed on each lead . - Rhythm Analysis Statements . - . Rhythm Graphical Statements - t Signal noise detection and information - . Specific findings on QRS complex - Conduction statements . - . QRS T Diagnostic statements - Summary of measurement performed on each lead .
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    K Number
    K091358
    Device Name
    ECSCOPE 100
    Manufacturer
    DYANSYS, INC.
    Date Cleared
    2009-05-28

    (20 days)

    Product Code
    DPS
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    DYANSYS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ECScope 100 hand held, battery operated 12 channel electrocardiograph is intended to be used for the diagnosis of cardiovascular system complications. ECScope 100 will acquire and record 12 ECG leads simultaneously. ECScope 100 is intended to be used by a licensed health care practitioner or under the direct supervision of a licensed health care practitioner in a hospital or health care environment. These measurements are not intended for a specific clinical diagnosis. The clinical significance of the ECG tracings must be determined by the physician in conjunction with clinician's knowledge of patient, the results of physical examination and other clinical findings.
    Device Description
    ECScone 100 is designed to acquire, display and record ECG signals from surface electrodes. The device consists of two basic components: the processing unit and the patient acquisition module. ECScope 100 is a multi channel electrocardiograph for the simultaneous acquisition of the 12 ECG leads i.e L1, L2, L3, aVR, aVL, aVf, V1, V2, V3, V4, V5 & V6, featuring Display Unit, alphanumeric keyboard and an option to print the ECG data by transferring the image file to computer through USB key or USB Cable on A4 Sheet Paper or Direct Printing through connected printer. ECScope 100 can record and store in its Database up to 30 ECG tests. Each ECG test can include patient data, doctor's information and ECG measurements. Stored ECG tests can be printed on the external printer by directly connecting the printer or by transferring data through USB cable/Key using a PC.
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