# K131917: Neurodyn Compact, Neurodyn II

- Pathway: 510(k) (Traditional)
- Applicant: Ibramed Equipamentos Medicos
- Decided: Apr 29, 2014 after 307 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- 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.
1 later device descends from it; 1 cites it directly.
0 of 8 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.

## Most influential descendants
- K181645: StimaWELL 120MTRS (2020), 0 descendants of its own

## Indications for use
Indications for FES waveform: - Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait. Indications for TENS waveform: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post surgical pain Indications for Russian waveform: - Temporary relaxation of muscle spasms - Prevention or retardation of disuse atrophy in post-injury type conditions - Increase local blood circulation - Muscle re-education - Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K131917
Methodology: https://510kreport.com/methodology