← Product Code [HCB](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCB) · K853178

# SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM (K853178)

_Oxford Medilog, Inc. · HCB · Feb 28, 1986 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCB/K853178

## Device Facts

- **Applicant:** Oxford Medilog, Inc.
- **Product Code:** [HCB](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCB.md)
- **Decision Date:** Feb 28, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.5235
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

An aversive conditioning device is an instrument used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics.

## Special Controls

*Classification.* Class II (special controls), except for electrical stimulation devices for self-injurious or aggressive behavior. Electrical stimulation devices for self-injurious or aggressive behavior are banned. See § 895.105 of this chapter.

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCB/K853178](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HCB/K853178)

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