# K982950: Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550

- Pathway: 510(k) (Traditional)
- Applicant: Chalgren Enterprises, Inc.
- Decided: Jun 22, 1999 after 305 days
- Product code: IKT (Electrode, Needle, Diagnostic Electromyograph)
- Device class: 2
- Regulation: 21 CFR 890.1385
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K011818: Sterile Emg Electrodes (2001), 1 descendant of its own
- K111131: Teca (TM) Elite Disposable Monopolar Needles (2011), 0 descendants of its own

## Indications for use
Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests. This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments. The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current. Fine wire electrodes allow for multiple tests without additional needle sticks.

Source page: https://510kreport.com/device/K982950
Methodology: https://510kreport.com/methodology