# K932849: Pmi Tens Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Pepin Mfg., Inc.
- Decided: Jan 27, 1994 after 231 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
No predicates in its family tree.
41 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K020735: Sof-Pach Reusable Neurostimulation Electrodes (2002), 32 descendants of its own
- K080276: Self-Adhesive Electrodes (2008), 31 descendants of its own
- K090198: Jiajian Self-Adhesive Electrode (2009), 26 descendants of its own
- K132998: Wandy Self-Adhesive Electrodes (2013), 16 descendants of its own
- K160138: Adhesive Electrodes (2016), 15 descendants of its own

Source page: https://510kreport.com/device/K932849
Methodology: https://510kreport.com/methodology