# K024377: Transcranial Electrotherapy Stimulator-a, Model Tesa-1

- Pathway: 510(k) (Traditional)
- Applicant: Kalaco Scientific, Inc.
- Decided: Jul 21, 2003 after 202 days
- Product code: QJQ (Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety)
- Device class: 2
- Regulation: 21 CFR 882.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K883812 (1988). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903654: Liss Cranial Stimulator Model SBL202-B, Medical Consultants Intl., Ltd. (1990) Summary page 1.
- K883812: HP-1 (Healthpax), Healthdirections, Inc. (1988) Summary page 1.
- (no number) Alpha-Stim CS: named in the summary without a submission number

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

Source page: https://510kreport.com/device/K024377
Methodology: https://510kreport.com/methodology