# K061343: Inspirstar Glove Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Inspirstar, Inc.
- Decided: May 31, 2006 after 16 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: 2 generations back to K932299 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053214: Theraknit Garment Electrode, Neurotron Medical (2005) Summary page 2.

## Indications for use
Inspirstar Glove Electrode is cutaneous electrode to be used with legally marketed TENS stimulating device. The glove electrodes will deliver the stimulation signals generated by the stimulator to the skin with which they are contact.

Source page: https://510kreport.com/device/K061343
Methodology: https://510kreport.com/methodology