# K871222: Tantone Multi-Day #633 Tens Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Uni-Patch, Inc.
- Decided: May 29, 1987 after 63 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K983097: Tens/Fes/Nmes Electrodes (1999), 8 descendants of its own
- K070807: Cutaneous Electrotherapy and Recording Electrodes; Tens Electrodes (2007), 6 descendants of its own
- K080386: Columbia 600 Electrode, Columbia 06 Leadwire (2008), 4 descendants of its own
- K083756: Guardian 150 Electrode (2009), 3 descendants of its own
- K121483: Reusable Cutaneous Electrode (2012), 1 descendant of its own

Source page: https://510kreport.com/device/K871222
Methodology: https://510kreport.com/methodology