510(k) · Cleared
ClearedInterferential Stimulator, Model RTM1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ryan Telemedicine · IPF Stimulator, Muscle, Powered
Cleared on Feb 26, 2003 after a 33-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 26, 2003
- Review
- 33 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK030254 Interferential Stimulator, Model RTM1000Ryan Telemedicine · 2003
- Descendant · cites it directly · 0 of its ownK042057 Infinity Electrotherapy SystemEmpi · 2004
Most influential descendants
Showing 1 of 1 · See all- K042057Infinity Electrotherapy SystemEmpi · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030254 | Interferential Stimulator, Model RTM1000 | Ryan Telemedicine | 2003 | — |
| +1 | K042057 | Infinity Electrotherapy System | Empi | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 19.6 · 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? (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 |
|---|---|---|---|
| * | — | CS3101 Interferential Stimulator Named without a submission number |
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 |
|---|---|---|---|
| K042057 | Infinity Electrotherapy System | 2004 | 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?
- Of its descendants, K042057 (Empi, 2004) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The RTM1000 Electrotherapy device is a multifunction nerve stimulation device intended to be used for muscle and nerve stimulation using any one of its two therapy modes, Interferential Current Stimulation, Neuromuscular Electrical Stimulation. In the Interferential Current Mode the RTM1000 is indicated for the following conditions: Symptomatic relief of pain Symptomatic management and relief of chronic pain Adjunctive treatment for the management of…
Read the full statement (115 words)
The RTM1000 Electrotherapy device is a multifunction nerve stimulation device intended to be used for muscle and nerve stimulation using any one of its two therapy modes, Interferential Current Stimulation, Neuromuscular Electrical Stimulation.
In the Interferential Current Mode the RTM1000 is indicated for the following conditions:
Symptomatic relief of pain
Symptomatic management and relief of chronic pain
Adjunctive treatment for the management of post traumatic and post-surgical pain.
In the Neuromuscular Stimulation Mode, the RTM1000 is indicated for the following conditions:
Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy;
Increasing local blood circulation;
Muscle re-education;
Immediate post surgical stimulation of calf muscle to prevent venous thrombosis; and
Maintaining or increasing range of motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030254: Interferential Stimulator, Model RTM1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030254
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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