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510(k) Data Aggregation

    K Number
    K213120
    Device Name
    OW100S (model OW100S-US)
    Manufacturer
    Tissue Regeneration Technologies, LLC DBA as SoftWave TRT
    Date Cleared
    2022-10-12

    (380 days)

    Product Code
    ISA
    Regulation Number
    890.5660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tissue Regeneration Technologies, LLC DBA as SoftWave TRT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OW100S (model OW100S-US) is intended for: - Relief of minor muscle aches and pains - Temporary increase in local blood circulation - Activation of connective tissue
    Device Description
    The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a high voltage spark in water which creates the acoustic waves that rapidly expand, which in turn are propagated through a coupling membrane attached to the hand-held applicator, which is water-filled. The hand-held applicator reflects the acoustic waves towards the treatment area through a silicone membrane and ultrasound transmission gel. The modification to the OrthoGold 100 (OW100) , identified as model OW100S and applicator OP155S, includes the addition of a "break circuit" added to the acoustic wave generator which increases the available pulses per handheld applicator/electrode from 100K pulses to 500K pulses at low energy flux density in the device (increase from 70K to 350K pulses at higher energy flux density). As a consequence of this change, there are minor changes to the applicator and its connection, software and water cartridge of the device. Minor labeling changes are limited to product information and set-up details with regard to attachment and detection of the applicator, and water cartridge handling. There are no changes to the power output performance, electrode and reflector geometry, total primary electrical energy, energy flux density or penetration as a result of this change. New pressure measurements show little differences to previous measurements, however differences are of statistical nature.
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