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510(k) Data Aggregation
K Number
K130978Device Name
ZTX ULTRASONIC DIATHERMY DEVICE
Manufacturer
ZetrOZ INC
Date Cleared
2013-11-06
(211 days)
Product Code
PFW
Regulation Number
890.5300Why did this record match?
Applicant Name (Manufacturer) :
ZetrOZ INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZTX Ultrasonic Diathermy Device is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.
The ZTX Ultrasonic Diathermy Device is a prescription use device. The ZTX Device should only be administered and monitored by a licensed healthcare practitioner.
Device Description
The ZTX Ultrasonic Diathermy Device consists of a ZTX Ultrasound Power Controller and cable which can be used to power one or two ZTX Ultrasound Applicators simultaneously that each generate ultrasonic energy at one frequency (3 MHz) and one power setting (0.65 W) per ZTX Ultrasound Applicator. The ZTX Ultrasound Applicators are applied with one time use ZTX Ultrasound Coupling Bandages which hold the ZTX Ultrasound Applicators in place during treatment and allow for the transmission of ultrasound into the body. This provides the operator with the ability to use the device hands-free in a single applicator mode of operation that delivers 0.65W at 3MHz or in a dual applicator mode of operation that provides 1.3W at 3MHz. The ZTX Ultrasound Power Controller displays battery and treatment setting information to the operator and provides control of device treatment time. The ZTX Ultrasound Applicator frequency and power settings are not modifiable by the operator. The ZTX ultrasound applicators and coupling bandage allows for the delivery of ultrasonic energy to tissue at one or two locations simultancously, as determined by a physician. The ZTX Ultrasound Power Controller , ZTX Ultrasound Applicators, interconnecting power cable and ZTX Ultrasound Coupling Bandages comprise the entire ZTX treatment system.
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