# K131923: Neurodyn Portable Tens Nfes, Neurodyn Portable Tens

- Pathway: 510(k) (Traditional)
- Applicant: Techlink International
- Decided: Jul 3, 2014 after 372 days
- Product code: GZI (Stimulator, Neuromuscular, External Functional)
- Device class: 2
- Regulation: 21 CFR 882.5810
- 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 K931781 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121369: Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator, Ibramed Equipamentos Medicos (2012) Summary page 1.
- K021100: 300 PV Complete Electrotherapy System, Empi (2002) Summary page 1.

## Indications for use
indications for FES device: - Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patients gait. Indications for TENS device: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of past-traumatic acute pain and post surgical pain

Source page: https://510kreport.com/device/K131923
Methodology: https://510kreport.com/methodology