Device Description : A hand-held mains electricity electronic component of a wound therapy ultrasound A hand-held mains electricity electronic component of a wound therapy ultrasound system intended to convert (transduce) electrical energy into low frequency ultrasound energy for application to a wound site via a fluid mist to promote wound healing. It is a non-contact device which may include a display / controls, intended to connect proximally to the system generator and distally to a disposable applicator. It is used in conjunction with a fluid source such as saline with the ultrasound-conductive mist directed at the wound site for removal of fibrin, yellow slough, tissue exudates, and bacteria.
Device Class : 2
Duns Number: 872967679
Premarket Exempt : No
Prescription Use : Yes
Device Description : A portable assembly of mains electricity devices intended to deliver low frequen A portable assembly of mains electricity devices intended to deliver low frequency ultrasound energy via a fluid mist to a wound to promote healing of the wound without direct wound contact. The generator generates radio-frequency electrical energy which is subsequently transduced into ultrasound energy in the system treatment wand and pumps a fluid solution for the production of an ultrasound-conductive mist used to promote wound healing. The generator is intended to be used in conjunction with a system treatment wand and fluid source such as saline.
Device Class :
Duns Number: 872967679
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile component of a wound therapy ultrasound system intended to be attached A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device.
Device Class :
Duns Number: 872967679
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile component of a wound therapy ultrasound system intended to be attached A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. it typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device.
Device Class : 2
Duns Number: 872967679
Premarket Exempt : No
Prescription Use : Yes
Device Description : A sterile component of a wound therapy ultrasound system intended to be attached A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. This is a single-use device.
Device Class : 2
Duns Number: 872967679
Premarket Exempt : No
Prescription Use : Yes