Address:977 Pruitt,Tyler,TX,75703,US
Device Description : The UroShield disposable Actuator is a single catheter use accessory that is cli The UroShield disposable Actuator is a single catheter use accessory that is clipped on the catheter's external part.After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
Device Class :
Duns Number: 080326793
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : A package of 10 x UroShield disposable Actuators The UroShield is a single cathe A package of 10 x UroShield disposable Actuators The UroShield is a single catheter use accessory that is clipped on the catheter's external part.After connection to the reusable Driver and activation, Actuator creates surface acoustic waves that cause small acoustic vibrations on the catheter surface to prevent bacteria adhesion to the catheter surface.
Device Class :
Duns Number: 080326793
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : The UroShield device is a single-patient, extracorporeal accessory to indwelling The UroShield device is a single-patient, extracorporeal accessory to indwelling urinary catheters consisting of a disposable Actuator and a reusable Driver. After the Foley catheter is placed in the patient, the disposable Actuator is clipped on the extracorporeal part of the catheter and then connected to the reusable Driver through the Actuator’s cable connector and Driver’s cable socket connection. When the Driver is turned on, the Actuator creates surface acoustic waves that propagate on the catheter surface. The UroShield surface acoustic waves reduce bacterial adhesion on the catheter surface, thereby designed to minimize the risk of CAUTI (Catheter-Associated Urinary Tract Infections).
Device Class :
Duns Number: 080326793
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : PainShield MD applies ultrasound energy through a treatment patch that is placed PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves and a portable battery-operated driver.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Monthly kit includes a treatment actuator that incorporates an ultrasonic tr The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable.The transducer is applied to the patient skin using single use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Reusable Patch is a small lightweight treatment patch, which is attached to The Reusable Patch is a small lightweight treatment patch, which is attached to the user's skin at the location of the pain. The patch is energized with a signal from the PainShield's driver and creates mechanical vibrations via piezo-electric element. After the use patch should be covered with its original liner till next use.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes
Device Description : PainShield MD is intended to apply ultrasonic energy to generate deep heat withi PainShield MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low frequency ultrasound energy is effective within a diameter of 20 cm and a depth of approximately 3 cm.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Reusable Facial Patch is a small, lightweight treatment patch, which is atta The Reusable Facial Patch is a small, lightweight treatment patch, which is attached to the user's skin at the location of the pain. The patch is energized with a signal from PainShield's driver and creates mechanical vibrations via the piezo-electric element. after the use patch should be covered with its original liner till next use.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Monthly kit includes a treatment actuator that incorporates an ultrasonic tr The Monthly kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable. The transducer is applied to the patient skin using single-use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes
Device Description : PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low-frequency ultrasound energy is effective within a diameter of 20 cm and depth of approximately 3 cm.
Device Class : 2
Duns Number: 080326793
Premarket Exempt : No
Prescription Use : Yes