MEDAC SYSTEM/3
Device Facts
| Record ID | K914925 |
|---|---|
| Device Name | MEDAC SYSTEM/3 |
| Applicant | Davicon, Inc. |
| Product Code | HCC · Neurology |
| Decision Date | Oct 21, 1993 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5050 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
