# K080221: EA Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Helio Medical Supplies, Inc.
- Decided: Sep 9, 2008 after 224 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K904388 (1991). 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)
- K051020: ES-160, Lhasa Oms, Inc. (2006)

## Indications for use
This device is designed to be used in the treatment of chronic, acute, and post-surgical pain.

Source page: https://510kreport.com/device/K080221
Methodology: https://510kreport.com/methodology