Device, Aversive Conditioning
The Aversive Conditioning Device is a behavioral therapy device that delivers mild unpleasant stimuli, such as a mild electric shock, in response to specified behaviors, used as part of a structured behavioral treatment program to reduce self-injurious or other targeted behaviors in patients with severe behavioral disorders. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is HCB under regulation 21 CFR 882.5235 in the Neurology specialty. It is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- HCB
- Device Class
- FDA class 2
- Regulation Number
- 882.5235
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911820 | GED (GRADUATED ELECTRONIC DECELERATOR | Dec 05, 1994 | Substantially Equivalent | Behavior Research Institute, Inc. |
| K871158 | SIBIS REMOTE ACTUATOR | May 29, 1987 | Substantially Equivalent | Human Technologies, Inc. |
| K853178 | SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM | Feb 28, 1986 | Substantially Equivalent | Oxford Medilog, Inc. |
| K820622 | ELECTROSTIMULI AVERSION MACHINE | Apr 09, 1982 | Substantially Equivalent | Michael R. Kiss |
| K790738 | HABITSABATER | Jun 20, 1979 | Substantially Equivalent | Jackson Ent. |
| K760166 | STIMULATOR, SONIC CONTROL (AS-1) | Jul 20, 1976 | Substantially Equivalent | Farrall Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.