# K210572: Neurodyn V2.0, Neurodyn Aussie V2.0

- Pathway: 510(k) (Traditional)
- Applicant: Ibramed Equipamentos Medicos
- Decided: May 11, 2021 after 74 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: 3 generations back to K931781 (1993). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131629: Neurodyn Multiwave, Aussie Sport, Ibramed Equipamentos Medicos (2013) Summary page 5.
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 5.

## Indications for use
Neurodyn V2.0 Stimulators are intended for: 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 As a High Voltage Pulsed current device: - Muscle re-education - Relaxation of Muscle Spasms - Maintaining or increasing range of motion - Increasing local blood circulation - Prevention or retardation of disuse atrophy Neurodyn Aussie V2.0 Stimulators are intended for: 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

Source page: https://510kreport.com/device/K210572
Methodology: https://510kreport.com/methodology