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510(k) Data Aggregation
K Number
K162240Device Name
ProMedTek Model C1400 Shortwave Diathermy Device
Manufacturer
PROMEDTEK INC.
Date Cleared
2016-11-17
(100 days)
Product Code
IMJ
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
PROMEDTEK INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ProMedTek Model C1400 Shortwave Diathermy device delivers energy in the radio band of 27.12 MHz to provide deep heating therapeutic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:
1. Relieving pain
2. Reducing muscle spasm
3. Increasing range of motion of contracted joints using heat and stretch techniques
4. Increasing blood flow to tissues in the treatment area.
Device Description
The ProMedTek C1400 shortwave diathermy device operates at 27.12 MHz. It provides traditional shortwave diathermy using an inductive drum or soft-rubber electrodes. The unit offers both continuous or pulsed modes of operation with a variety of frequencies and pulse widths to choose from. An easy-to-use LCD Touch Screen guides the user through setup. A Patient Safety Pull-Cord allows the patient to stop all output. The base of the ProMedTek C1400 is a sturdy cart with large locking wheels that allows the ProMedTek C1400 to be moved easily around the clinic and supports the arm and drum applicator during treatment.
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