# K070612: Top-Rank Adhesive Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Top-Rank Health Care Equipment Co., Ltd.
- Decided: May 7, 2007 after 63 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
No predicates in its family tree.
35 later devices descend from it; 3 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
Top-Rank Adhesive Electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Top-Rank Adhesive Electrodes are intended to be used with marketed, Electrical Stimulators i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular 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/K070612
Methodology: https://510kreport.com/methodology