510(k) · Cleared
ClearedNeurodyn Multiwave, Aussie Sport
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ibramed Equipamentos Medicos · IPF Stimulator, Muscle, Powered
Cleared on Nov 26, 2013 as substantially equivalent to K121369 (Ibramed Equipamentos Medicos, 2012) and 2 other predicates after a 175-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Nov 26, 2013
- Review
- 175 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K931781 (1993). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK931781 Jace Tri-Stim DeviceJace Systems, Inc. · 1993
- 1 generation backK021100 300 PV Complete Electrotherapy SystemEmpi · 2002
- This deviceK131629 Neurodyn Multiwave, Aussie SportIbramed Equipamentos Medicos · 2013
- Descendant · cites it directly · 0 of its ownK210572 Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos · 2021
Most influential descendants
Showing 1 of 1 · See all- K210572Neurodyn V2.0, Neurodyn Aussie V2.0Ibramed Equipamentos Medicos · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931781 | Jace Tri-Stim Device | Jace Systems, Inc. | 1993 | — |
| −1 | K021100 | 300 PV Complete Electrotherapy System | Empi | 2002 | — |
| 0 (this device) | K131629 | Neurodyn Multiwave, Aussie Sport | Ibramed Equipamentos Medicos | 2013 | — |
| +1 | K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | Ibramed Equipamentos Medicos | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K121369 | Neurodyn Ruby Muscle Stimulator, Neurodyn Aussie Muscle StimulatorSummary page 1…scle stimulator LIH - Interferential Current Thera py-Pre-amend ment GZI- 21 CER 882.5890 -External functional neuromuscular stimulator Predicate Device Identification: K121369 Neurodyn/Neurodyn Aussie Powered Muscle Stimulator K021100 300 PV Complete Electrotherapy K031077 Vectra Genisys Predicate devic… | 2012 |
| * | K021100 | 300 PV Complete Electrotherapy SystemSummary page 1…mend ment GZI- 21 CER 882.5890 -External functional neuromuscular stimulator Predicate Device Identification: K121369 Neurodyn/Neurodyn Aussie Powered Muscle Stimulator K021100 300 PV Complete Electrotherapy K031077 Vectra Genisys Predicate devices had been submitted and cleared by 510(k) for the same in… | 2002 |
| * | K031077 | Vectra Epr System and Intelect Epr SystemSummary page 1…l functional neuromuscular stimulator Predicate Device Identification: K121369 Neurodyn/Neurodyn Aussie Powered Muscle Stimulator K021100 300 PV Complete Electrotherapy K031077 Vectra Genisys Predicate devices had been submitted and cleared by 510(k) for the same intended uses and IBRAMVE… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210572 | Neurodyn V2.0, Neurodyn Aussie V2.0 | 2021 | 0 |
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 11.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K210572 (Ibramed Equipamentos Medicos, 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K121369.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
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…
Read the full statement (268 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131629: Neurodyn Multiwave, Aussie Sport.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131629
Report an extraction error
Are you the manufacturer?
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