SIBIS REMOTE ACTUATOR
FDA 510(k) clearance K871158 · decided 1987-05-29
Clearance details
- K-number
- K871158
- Device name
- SIBIS REMOTE ACTUATOR
- Applicant
- Human Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-24
- Decision date
- 1987-05-29
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- HCB
- Device class
- 2
- Regulation number
- 882.5235
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- St. Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GED (GRADUATED ELECTRONIC DECELERATOR (K911820) | Behavior Research Institute, Inc. | 1994-12-05 |
| SIBIS SELF INJURIOUS BEHAVIOR INHIBITING SYSTEM (K853178) | Oxford Medilog, Inc. | 1986-02-28 |
| ELECTROSTIMULI AVERSION MACHINE (K820622) | Michael R. Kiss | 1982-04-09 |
| HABITSABATER (K790738) | Jackson Ent. | 1979-06-20 |
| STIMULATOR, SONIC CONTROL (AS-1) (K760166) | Farrall Instruments, Inc. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.