# K011691: Kimstim Auricular Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Kim Institute For Rehabilitation Medicine, P.C.
- Decided: Dec 27, 2001 after 210 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The KimStim Auricular Electrode is designed as an accessory device intended to be used as prescribed for electro acupuncture treatments. It is customized for a single patient use and is re-useable. General warnings, precautions, contraindications and hazards are as directed and associated with the specific TENS generators to be used by the patient.

Source page: https://510kreport.com/device/K011691
Methodology: https://510kreport.com/methodology