# K070412: Elexoma Medic

- Pathway: 510(k) (Traditional)
- Applicant: Redplane AG
- Decided: May 21, 2008 after 464 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The "Elexoma Medic" is a battery operated portable cranial electrotherapy stimulator (CES) device that applies electrical current to a patient's head through electrodes clipped onto the patient's earlobes to treat insomnia, depression, or anxiety and The "Elexoma Medic" is a battery operated portable transcutaneous electrical nerve stimulator (TENS) device used to apply microcurrent through self-adhesive electrodes to a patient's skin for the symptomatic relief of intractable pain, chronic intractable pain, post-traumatic and post-surgical pain relief.

Source page: https://510kreport.com/device/K070412
Methodology: https://510kreport.com/methodology