510(k) · Cleared
ClearedFlex-MI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emsi, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Oct 21, 2022 as substantially equivalent to K112348 (Rs Medical, 2012) after a 108-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 21, 2022
- Review
- 108 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000114 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K112348 | RS-4I Muscle StimulatorSummary page 4…gulatory Class: II Regulation: 21 CFR 890.5850, 21 CFR 882.5890 Product Codes: IPF Powered Muscle Stimulator, LIH Interferential Current Therapy Predicate Device(s): K112348 RS-4I Plus Reference devices: K140467 Flex MT Plus, K071869 Flex IT (TENS/IF 14) Device Description: The Flex-MI is a combi… | 2012 |
| † | K140467 | Flex-MT + | 2014 |
| † | K071869 | Tens/IF 14 | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Interferential Stimulation
> Symptomatic relief of chronic intractable pain
> Adjunctive treatment for the management of post-traumatic or post-surgical pain
EMS (Electrical Muscle Stimulation)
> Relaxation of muscle spasm
> Increasing local blood circulation
> Muscle re-education
> Prevention or retardation of disuse atrophy
> Prevention of venous thrombosis of the calf muscles immediately after surgery
> Maintaining or increase range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221958: Flex-MI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221958
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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