SIBIS REMOTE ACTUATOR
Device Facts
| Record ID | K871158 |
|---|---|
| Device Name | SIBIS REMOTE ACTUATOR |
| Applicant | Human Technologies, Inc. |
| Product Code | HCB · Neurology |
| Decision Date | May 29, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5235 |
| Device Class | Class 2 |
Regulatory Classification
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.
