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Habitsabater

by Jackson Ent.

510(k) K790738

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 NumberK790738 Date20 Jun 1979ClearedStatusActive

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  • Withdrawn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, 25 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 HABITSABATER is a device for aversive conditioning used in neurology. It is classified as a Class II medical device under product code HCB.

The device is manufactured by Jackson Ent. and received FDA 510(k) clearance on June 20, 1979. It is supplied as a single unit and is not specified as single-use or reusable. No MRI safety information is provided in the data.

Questions

AI-generated answers, 25 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 HABITSABATER device used for?

    The HABITSABATER is a medical device designed for aversive conditioning in neurology. It is classified as a Class II medical device under product code HCB and manufactured by Jackson Ent.

  • How is the HABITSABATER supplied?

    The HABITSABATER is supplied as a single unit. The device data does not specify whether it is intended for single-use or reusable purposes.

  • What is the regulatory status of the HABITSABATER?

    The HABITSABATER received FDA 510(k) clearance on June 20, 1979. It is classified as a Class II medical device under product code HCB and was reviewed by the Neurology advisory committee.

  • Is the HABITSABATER MRI safe?

    No MRI safety information is provided in the device data for the HABITSABATER. Users should consult the manufacturer for specific MRI compatibility information.