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510(k) Data Aggregation
K Number
K965244Device Name
Z TECH TRANSCUTANEOUS NEURAL STIMULATION
Manufacturer
Date Cleared
1997-08-27
(246 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Z TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used by clinicians in symptomatic relief of chronic intractable pain. Also, for post traumatic and post surgical pain relief.
Device Description
The Z Tech Tens Device is designed to produce 0-60μc H-WAVE type pulse which is described as a bi-polar asymmetrical exponentially decaying impulse type waveform. It has a pulse width of approximately 1.5ms and and delivers a maximum frequency of 55Hz. Essentially the device originates an astable type pulse of controllable peak voltage, frequency and pulse width, which is amplified and passed to the output electrodes through an isolation transformer, which also eliminates any D.C. component in the output. The device also employs a recharging type circuit which effectively inhibits any patient use during the recharging of permanently installed ni-cad type batteries. The case which is of a lexan plastic type material. Front and rear controls are clearly marked as to their function for ease of patient use.
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