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FDA Safety Leadwire Directive

The US Food and Drug Administration has mandated (21 CFR Part 898, Medical Devices; Establishment of a Performance Standard for Electrode Lead Wires and Patient Cables) that original equipment manufacturers and third-party suppliers will not be able to sell unprotected or non-compliant leadwires after May 9th, 2000.

The distinction is fairly simple.

          Compliant: No exposed metal on the part of the leadwire that attaches to the device.

          Non-Compliant: Exposed metal on the part of the leadwire that attaches to the device.

This does not mean that older, non-compliant devices (devices that accept non-compliant leadwires) will be recalled or banned. However, once these non-compliant leadwires become faulty, your patients will not be able to get replacements.

I am sure you are aware that since 1998, American Imex has been working diligently on not only updating existing units, but more importantly, keeping you current on this key issue affecting our industry. You may also have noticed recent changes with the units that you order as well as read some of our notices and bulletins that we include with your shipment.

If you have any questions, please feel free to us at 800-521-8286 or email at [email protected]

 

Deep penetrating soothing pain relief!

 

The ST302 Infracare therapeutic heat lamp features the naturally soothing deep heat as only an infrared light can provide. Best of all, it is recommended by healthcare professionals, massage therapists, and pain specialists for the temporary pain relief of muscular pain, sore muscles, arthritis, bursitis, back ache, tennis elbow, joints, and related pains.

Infrared light and heat penetrates far below the surface of the skin to give soothing, comfortable relief without the side effects of pills and medication.

The Infracare is hand held and ergonomically designed for ease of use. Two heat settings are offered to suit your specific needs. The Infracare is UL and CSA tested and operates from an AC power source. It comes with a 90 day warranty against all manufacturers defects.

Similar units on the internet sell for as much as 4 times the cost. Buy direct from us and save!


$9.95 each!

 

 

 

 

 

 

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