# K083756: Guardian 150 Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Selectivemed Components, Inc.
- Decided: Jun 26, 2009 after 191 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: 4 generations back to K871222 (1987). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023347: Vital Stim, Chattanooga Group (2002) Summary page 1.
- K945676: Guardian Disposable Tens and Tens/Nmes Electrodes, Selectivemed Components, Inc. (1995) Summary page 1.
- K080386: Columbia 600 Electrode, Columbia 06 Leadwire, Columbia Scientific Development, LLC (2008) Summary page 1.

## Most influential descendants
- K121483: Reusable Cutaneous Electrode (2012), 1 descendant of its own
- K172887: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) (2018), 0 descendants of its own
- K113375: Eswallow Usa Electrode,Eswallow Usa Leadwire (2013), 0 descendants of its own

## Indications for use
Guardian 150 electrode is indicated for use with TENS and NMES, including for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.

Source page: https://510kreport.com/device/K083756
Methodology: https://510kreport.com/methodology