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510(k) Data Aggregation

    K Number
    K223620
    Device Name
    Reprieve by RegenesisTM
    Manufacturer
    Regenesis Biomedical Inc.
    Date Cleared
    2023-05-24

    (170 days)

    Product Code
    IMJ
    Regulation Number
    890.5290
    Why did this record match?
    Applicant Name (Manufacturer) :

    Regenesis Biomedical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reprieve by Regenesis™ device is indicated to generate deep heating within body tissues for the treatment of conditions such as relief of pain and muscle spasms.
    Device Description
    The Reprieve by Regenesis™ device (Reprieve) is a prescription shortwave diathermy (SWD) device consisting of a single base unit connected to one or two treatment applicators. The device connects to A/C power through an external, off-the-shelf, power supply generating radiofrequency energy which delivers SWD through the treatment applicator(s). The base unit houses an LCD screen with four raised buttons, two on each side of the LCD screen, and an LED light bar. The back of the base unit has a molded slot to accommodate the treatment applicator(s), a pouch to store the power supply, and a cable wrapping loop to organize the treatment applicator cables. The bottom of the base unit has an opening to connect the A/C power supply. The treatment factory-affixed coaxial cables. The top is the treatment side of the applicator is a darker color to distinguish it from the lighter-colored bottom, the non-treatment side. The top also has circular imagery denoting the center of the applicator. The Reprieve device generates a 27.12 MHz RF signal that has a 100% duty cycle when programmed to continuous wave (CW) mode. When prescribed for pulsed wave (PW) mode, the pulse rate (e.g., pulses per second) can be varied from 200Hz to 1000Hz in 200Hz increments, and the pulse width (e.g., the elapsed time the pulse is on) from 20µsec to 100µsec in 20µsec increments.
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