510(k) Report

510(k) · Cleared

Cleared

Transcranial Electrotherapy Stimulator-a, Model Tesa-1

K024377510(k) TraditionalCleared Jul 21, 2003202-day reviewClass II21 CFR 882.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kalaco Scientific, Inc. · QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Cleared on Jul 21, 2003 as substantially equivalent to K903654 (Medical Consultants Intl., Ltd., 1990) and 1 other predicate after a 202-day review. Its family tree reaches back 1 generation to 1988.

Decided
Jul 21, 2003
Review
202 days
Class
Class II
Product code
QJQ
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K883812 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1990: 1 other ancestorK883812 · HP-1 (Healthpax) · Healthdirections, Inc. · 1988 · recalled19851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor K883812 · HP-1 (Healthpax) · Healthdirections, Inc. · 1988 · recalled0
  1. Root · 1 generation backK883812 HP-1 (Healthpax)Healthdirections, Inc. · 1988 · Recalled
  2. This deviceK024377 Transcranial Electrotherapy Stimulator-a, Model Tesa-1Kalaco Scientific, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K883812HP-1 (Healthpax)Healthdirections, Inc.19881
0 (this device)K024377Transcranial Electrotherapy Stimulator-a, Model Tesa-1Kalaco Scientific, Inc.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
FIG. 1 — Lineage of K024377, 1988–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QJQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QJQ device

  1. #1 K252951 Genesis Sleepscore 11.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K903654Liss Cranial Stimulator Model SBL202-B
Summary page 1
…. _ _ _ Liss Cranial Stimulator, SBL202-B K903654 HealthPax HP-1 K883812 Description of the Device and Summar…
Medical Consultants Intl., Ltd.19901
*K883812HP-1 (Healthpax)
Summary page 1
…Liss Cranial Stimulator, SBL202-B K903654 HealthPax HP-1 K883812 Description of the Device and Summary of the Technological Characteristics: The TESA is a transcranial electrotherapy stimulat…
Healthdirections, Inc.19881
*—Alpha-Stim CS
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.

How does its category compare?

All QJQ devices

QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · QJQ

1in 2025

2007: 12008: 12009: 12019: 12023: 12024: 12025: 1
2007high 1 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QJQ

Too few QJQ 510(k)s in any year since 2007 to give a median.

Recalls per year · QJQ

No recall names QJQ since 2007.

Adverse event reports per year · QJQ

39in 2023

2023: 39
2007high 39 (2023) · low 0 (2007)2025

MAUDE reports naming product code QJQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20081—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20231—039
20241—00
20251—00
20260—0—

What is it indicated for?

Treatment with the TESA device is intended to reduce the symptoms of depression, anxiety and insomnia.

Indications for use as stated in the FDA summary.

Recent decisions in QJQ

The QJQ category page

  • K252951Genesis SleepNeurofield, Inc. · 2025
  • K232253Modius StressNeurovalens Limited · 2024
  • K230826Modius SleepNeurovalens, Ltd. · 2023
  • K182311CervellaInnovative Neurological Devices, LLC · 2019
  • K090052Cranial Electrical Nerve Stimulator, Model FM 10/CJohari Digital Healthcare, Ltd. · 2009

https://510kreport.com/device/K024377 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024377: Transcranial Electrotherapy Stimulator-a, Model Tesa-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024377

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026