# K020735: Sof-Pach Reusable Neurostimulation Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: Cathay International, Ltd.
- Decided: Jul 12, 2002 after 128 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 K903402 (1990). 4 ancestors in all.
32 later devices descend from it; 2 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963125: M and R Reusable Electrodes (Multiple), M & R Mfg., Inc. (1997) Summary page 1.
- K932849: Pmi Tens Electrode, Pepin Mfg., Inc. (1994) Summary page 1.
- K011411: Self-Adhesive Electrodes, Pain Management Technologies (2001)

## Most influential descendants
- K080276: Self-Adhesive Electrodes (2008), 31 descendants of its own
- K090198: Jiajian Self-Adhesive Electrode (2009), 26 descendants of its own
- K132998: Wandy Self-Adhesive Electrodes (2013), 16 descendants of its own
- K160138: Adhesive Electrodes (2016), 15 descendants of its own
- K180865: ZMI Self-Adhesive Electrodes (2018), 9 descendants of its own

## Indications for use
SOF-PACH™ Reusable Cutaneous Neurostimulation Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. SOF-PACH™ Reusable Electrodes are designed and intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) of PGF (Pulsed Galvanic Stimulation). These electrodes will include the precaution statement: Federal Law restricts the device to sale by or on the order of a licensed practitioner or therapist.

Source page: https://510kreport.com/device/K020735
Methodology: https://510kreport.com/methodology