# K131629: Neurodyn Multiwave, Aussie Sport

- Pathway: 510(k) (Traditional)
- Applicant: Ibramed Equipamentos Medicos
- Decided: Nov 26, 2013 after 175 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.
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 1.

## Most influential descendants
- K210572: Neurodyn V2.0, Neurodyn Aussie V2.0 (2021), 0 descendants of its own

## Indications for use
Neurodyn Multiwave - Indications for Use: As a 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 patient's gait. As a TENS device: - Symptomatic relief of chronic (long term) intractable pain - Symptomatic relief of post-traumatic acute pain and post-surgical pain As an Interferential and Premodulated device: - Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain As a Russian device: - 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 As a Burst Modulated Alternating Current (Aussie) device: - 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 - Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain As a Microcurrent device: - Symptomatic relief of chronic intractable pain - Symptomatic relief of post-traumatic acute pain and post-surgical pain As a DC/Polarized device: - Relaxation of Muscle Spasm Aussie Sport - Indications for Use: As an Burst Modulated Alternating Current (Aussie) device: - 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 - Symptomatic relief of chronic intractable pain, acute post traumatic pain, or acute post traumatic surgical pain

Source page: https://510kreport.com/device/K131629
Methodology: https://510kreport.com/methodology