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Conductance Meter (DCM). In 1992, James Hoyt Clark submitted
a 510(k) to the FDA for the DCM to be cleared for biofeedback
and used with relaxation training. The 510(k) allows the FDA
to compare new devices to older devices that were sold in
the United States before May 1976. It is referred to as a
"grandfather clause". The FDA compares medical claims
by a manufacturer in its 510(k) to previously cleared devices.
If the FDA finds the new device to be "substantially
equivalent" to the previously cleared device, the FDA
gives the new device a clearance to be marketed in the United
States using the claims in the 510(k). In 1996, the FDA cleared
the DCM for the claims submitted by Clark. The DCM claims
were that it could measure resistance, output a variable voltage
and generate a signal. Further, the FDA cleared the DCM for
relaxation training as a biofeedback device.
CEDS measures at acupuncture
points, which is a different use then most biofeedback devices.
In December 1996, the FDA reclassified acupuncture from Class
III to Class II, which is the same classification as biofeedback
devices.
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