# K993130: Ultra-Garment Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Newwave Medical, LLC
- Decided: Dec 17, 1999 after 88 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- 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 K932299 (1994). 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)
- K943009: SMD Electrodes, Scientific Medical Devices, Inc. (1995) Summary page 1.
- K932299: Electro-Mesh, Prizm Medical, Inc. (1994) Summary page 1.

## Indications for use
The “Ultra Garment Electrode” is intended to be used as an electrically conducting garment to be prescribed for usage by a physician for use where an electrode is appropriate.

Source page: https://510kreport.com/device/K993130
Methodology: https://510kreport.com/methodology