510(k) · Cleared
ClearedNeurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibramed Equipamentos Medicos · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Dec 19, 2012 as substantially equivalent to K031077 (Chattanooga Group, 2003) after a 226-day review. Its family tree reaches back 1 generation to 2003. 5 later devices descend from it.
- Decided
- Dec 19, 2012
- Review
- 226 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031077 (2003). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031077 Vectra Epr System and Intelect Epr SystemChattanooga Group · 2003 · Recalled
- This deviceK121369 Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle StimulatorIbramed Equipamentos Medicos · 2012
- Descendant · cites it directly · 1 of its ownK131917 Neurodyn Compact, Neurodyn IIIbramed Equipamentos Medicos · 2014
- Descendant · cites it directly · 1 of its ownK131629 Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos · 2013
- Descendant · 2 generations on · 0 of its ownK210572 Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos · 2021
- Descendant · 2 generations on · 0 of its ownK181645 StimaWELL 120MTRSPierenkemper GmbH · 2020
- Descendant · cites it directly · 0 of its ownK131923 Neurodyn Portable Tens Nfes, Neurodyn Portable TensTechlink International · 2014
Most influential descendants
Showing 5 of 5 · See all- K131917Neurodyn Compact, Neurodyn IIIbramed Equipamentos Medicos · 2014 · cites it directly1descendant
- K131629Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos · 2013 · cites it directly1descendant
- K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos · 2021 · 2 generations on0descendants
- K181645StimaWELL 120MTRSPierenkemper GmbH · 2020 · 2 generations on0descendants
- K131923Neurodyn Portable Tens Nfes, Neurodyn Portable TensTechlink International · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031077 | Vectra Epr System and Intelect Epr System | Chattanooga Group | 2003 | 17 |
| 0 (this device) | K121369 | Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator | Ibramed Equipamentos Medicos | 2012 | — |
| +1 | K131917 | Neurodyn Compact, Neurodyn II | Ibramed Equipamentos Medicos | 2014 | — |
| +1 | K131629 | Neurodyn Multiwave, Aussie Sport | Ibramed Equipamentos Medicos | 2013 | — |
| +2 | K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | Ibramed Equipamentos Medicos | 2021 | — |
| +2 | K181645 | StimaWELL 120MTRS | Pierenkemper GmbH | 2020 | — |
| +1 | K131923 | Neurodyn Portable Tens Nfes, Neurodyn Portable Tens | Techlink International | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031077 | Vectra Epr System and Intelect Epr SystemSummary page 2…Standards for the Development of Medical Devices (NBR NBR IEC 60601-1 IEC 60601-1-2 and lEG 60601-2-10 NBR). Predicate Device Identification: Chattanooga Vectra Genisys K031077 Predicate devices had been submitted and cleared by 510(k) for the same intended uses and indications. Device Description Neuro… | 2003 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (130 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121369 · printed Nov 5, 2026
Cite this page
510(k) Report. “K121369: Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K121369
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026