# K052875: Prostim Reusable Neurostimulation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Summit Manufacturing, LLC
- Decided: Dec 27, 2005 after 76 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 K945676 (1995). 5 ancestors in all.
22 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050469: EZ-Stik Electrodes, Naimco, Inc. (2005) Summary page 1.
- K010431: Lead-Lok Reusable Tens/ Nmes Electrodes, Lead-Lok, Inc. (2001) Summary page 1.

## Most influential descendants
- K062675: Gemore Reuseable Self Adhesive Electrode, Models Wire Series, Snap Series and Double Side Series (2007), 21 descendants of its own
- K083302: Lifecare Electrodes (2009), 14 descendants of its own
- K130987: Valutrode Neurostimlation Electrodes (2013), 10 descendants of its own
- K150971: Zekang Self-adhesive Electrode (2015), 5 descendants of its own
- K082065: Well Life Self Adhesive Electrode / Models: CM, FA, PU and SP (2009), 5 descendants of its own

## Indications for use
The ProStim Reusable Neurostimulation Electrodes are intended for use as a disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. ProStim Reusable Neurostimulation Electrodes are designed and intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation), MENS (Microcurrent Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation).

Source page: https://510kreport.com/device/K052875
Methodology: https://510kreport.com/methodology