# K041902: Mantra Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Mantra Intl. (Hk), Ltd.
- Decided: Sep 22, 2004 after 70 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: 2 generations back to K871222 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983097: Tens/Fes/Nmes Electrodes, Uni-Patch, Inc. (1999) Summary page 1.

## Indications for use
The Mantra Electrode is intended to be used with Transcutaneous Nerve Stimulator and Electronic Muscle Stimulator Units.

Source page: https://510kreport.com/device/K041902
Methodology: https://510kreport.com/methodology