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SIBIS Remote Actuator

by Human Technologies, Inc.

510(k) K871158

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK871158 Date29 May 1987ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HCB
Device Class
Class II
Regulation
21 CFR Part 882.5235
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SIBIS Remote Actuator is an aversive conditioning device used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics. It is classified as a Device, Aversive Conditioning under regulation number 882.5235 and falls within the Neurology medical specialty.

The device received traditional 510(k) clearance (K871158) from the FDA on May 29, 1987, and is classified as a Class II medical device. It was submitted by Human Technologies, Inc. and is identified by product code HCB. The device is intended for use in clinical settings where aversive conditioning is applied under professional supervision.

Other devices from Human Technologies, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SIBIS Remote Actuator used for?

    The SIBIS Remote Actuator is used to administer an electrical shock or other noxious stimulus to a patient to modify undesirable behavioral characteristics through aversive conditioning, and is intended for use in clinical settings under professional supervision.

  • How is the SIBIS Remote Actuator supplied or activated?

    The SIBIS Remote Actuator is a remote-controlled device designed to deliver aversive stimuli such as electrical shock; it is operated by a clinician to administer the stimulus during conditioning procedures, though specific activation method details are not provided in the data.

  • Is the SIBIS Remote Actuator reusable or single-use?

    The device data does not specify whether the SIBIS Remote Actuator is single-use or reusable; however, as an actuator designed for repeated clinical use in aversive conditioning, it is likely intended for multiple uses under professional supervision, but this should be confirmed with the manufacturer's labeling.

  • What regulatory pathway was used for the SIBIS Remote Actuator?

    The SIBIS Remote Actuator received traditional 510(k) clearance (K871158) from the FDA on May 29, 1987, and is classified as a Class II medical device under product code HCB and regulation number 882.5235.

  • In what medical specialty is the SIBIS Remote Actuator used?

    The SIBIS Remote Actuator falls within the Neurology medical specialty, as indicated in its FDA classification and openfda fields, and is used for aversive conditioning to modify behavior under professional supervision.