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Liss Cranial Stimulator Model SBL202-B

by Medical Consultants Intl., Ltd.

510(k) K903654

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK903654 Date4 Oct 1990ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1600-2023 FDA Class II initiated 6 Apr 2023

    If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

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  • Withdrawn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
QJQ
FDA applicant
Medical Consultants Intl. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 882.5800
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 LISS CRANIAL STIMULATOR MODEL SBL202-B is a cranial electrotherapy stimulator intended to treat insomnia and/or anxiety. It is classified as a Class II medical device under regulation number 882.5800 and has been determined to be substantially equivalent through the FDA 510(k) process.

The device was cleared via the traditional 510(k) pathway with K number K903654 and received FDA clearance on October 4, 1990. It is manufactured by Medical Consultants Intl., Ltd., and is authorized for use in the United States under product code QJQ and neurology specialty classification.

Other devices from Medical Consultants Intl., Ltd.

Questions

AI-generated answers, 23 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 LISS Cranial Stimulator Model SBL202-B used for?

    The LISS Cranial Stimulator Model SBL202-B is intended to treat insomnia and/or anxiety as a cranial electrotherapy stimulator, based on its FDA 510(k) clearance for this specific indication.

  • How was the LISS Cranial Stimulator Model SBL202-B authorized for use in the United States?

    The device received FDA clearance through the traditional 510(k) pathway with K number K903654 on October 4, 1990, and is authorized for use in the U.S. under product code QJQ and neurology specialty classification.

  • What regulatory classification and pathway apply to the LISS Cranial Stimulator Model SBL202-B?

    It is classified as a Class II medical device under regulation number 882.5800 and was determined to be substantially equivalent via the FDA 510(k) process, with clearance granted through the traditional pathway.