# K121369: Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator

- Pathway: 510(k) (Traditional)
- Applicant: Ibramed Equipamentos Medicos
- Decided: Dec 19, 2012 after 226 days
- Product code: GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief)
- Device class: 2
- Regulation: 21 CFR 882.5890
- 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 K031077 (2003). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031077: Vectra Epr System and Intelect Epr System, Chattanooga Group (2003) Summary page 2.

## Most influential descendants
- K131917: Neurodyn Compact, Neurodyn II (2014), 1 descendant of its own
- K131629: Neurodyn Multiwave, Aussie Sport (2013), 1 descendant of its own
- K210572: Neurodyn V2.0, Neurodyn Aussie V2.0 (2021), 0 descendants of its own
- K181645: StimaWELL 120MTRS (2020), 0 descendants of its own
- K131923: Neurodyn Portable Tens Nfes, Neurodyn Portable Tens (2014), 0 descendants of its own

## Indications for use
As a TENS device: Symptomatic relief of chronic (long term) intractable pain Symptomatic relief of post-traumatic acute pain and post-surgical acute 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 As a Microcurrent device: Symptomatic relief of chronic intractable pain Symptomatic relief of post-traumatic acute pain and post-surgical acute pain

Source page: https://510kreport.com/device/K121369
Methodology: https://510kreport.com/methodology