HCB · Device, Aversive Conditioning
Neurology · 21 CFR 882.5235 · Class 2
Overview
| Product Code | HCB |
|---|---|
| Device Name | Device, Aversive Conditioning |
| Regulation | 21 CFR 882.5235 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
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.
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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911820 | GED (GRADUATED ELECTRONIC DECELERATOR | Behavior Research Institute, Inc. | Dec 5, 1994 | SESE |
| K871158 | SIBIS REMOTE ACTUATOR | Human Technologies, Inc. | May 29, 1987 | SESE |
| K853178 | SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM | Oxford Medilog, Inc. | Feb 28, 1986 | SESE |
| K820622 | ELECTROSTIMULI AVERSION MACHINE | Michael R. Kiss | Apr 9, 1982 | SESE |
| K790738 | HABITSABATER | Jackson Ent. | Jun 20, 1979 | SESE |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | Farrall Instruments, Inc. | Jul 20, 1976 | SESE |
Top Applicants
- Behavior Research Institute, Inc. — 1 clearance
- Farrall Instruments, Inc. — 1 clearance
- Human Technologies, Inc. — 1 clearance
- Jackson Ent. — 1 clearance
- Michael R. Kiss — 1 clearance
