# K091056: Rhythmlink Disposable Monopolar Emg Needle, Model TFDN26032252R

- Pathway: 510(k) (Traditional)
- Applicant: Rhythmlink International, LLC
- Decided: Jun 23, 2009 after 71 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
Longest line of descent: 1 generation back to K071185 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071185: Modification to: Ambu Neuroline, Disposable Monopolar Needle Electrode, Ambu A/S (2007) Summary page 1.

## Indications for use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

Source page: https://510kreport.com/device/K091056
Methodology: https://510kreport.com/methodology