# K053214: Theraknit Garment Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Neurotron Medical
- Decided: Dec 20, 2005 after 33 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: 1 generation back to K932299 (1994). 3 ancestors in all.
29 later devices descend from it; 6 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932299: Electro-Mesh, Prizm Medical, Inc. (1994) Summary page 1.
- K944487: Electro-Mesh Sock, Wrap, and Sleeve Electrodes, Prizm Medical, Inc. (1995) Summary page 1.
- K943009: SMD Electrodes, Scientific Medical Devices, Inc. (1995) Summary page 1.

## Most influential descendants
- K103719: Lifecare Conductive Garments (2011), 20 descendants of its own
- K123354: Revitive IX (2013), 19 descendants of its own
- K143207: Revitive IX (OTC) (2015), 17 descendants of its own
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), 11 descendants of its own
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (2021), 5 descendants of its own

## Indications for use
The TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS stimulating device. The knitted garment electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand (glove), feet (socks), elbow or knee (sleeve), arm, leg, shoulder, back (pads).

Source page: https://510kreport.com/device/K053214
Methodology: https://510kreport.com/methodology