← Product Code [HCC](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC) · K861950

# THE FM-212A BIOFEEDBACK UNIT (K861950)

_Hosa Technology, Inc. · HCC · Apr 22, 1987 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K861950

## Device Facts

- **Applicant:** Hosa Technology, Inc.
- **Product Code:** [HCC](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC.md)
- **Decision Date:** Apr 22, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5050
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K861950](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCC/K861950)

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