# K902195: TBD Tens Reusable Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Empi
- Decided: Jun 8, 1990 after 23 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K100418: Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating Electrode (2010), 4 descendants of its own
- K182111: DL Self-adhesive Electrode (2019), 3 descendants of its own
- K241512: Electrode Pad (2025), 1 descendant of its own
- K253237: Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) (2026), 0 descendants of its own
- K183154: SM Electrodes (2019), 0 descendants of its own

## Recalls of this device
- Feb 9, 2012 · Class II · Z-0501-2013: Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have bee

Source page: https://510kreport.com/device/K902195
Methodology: https://510kreport.com/methodology