510(k) · Cleared
ClearedLegend Pro DMA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pollogen, Ltd. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Oct 21, 2021 as substantially equivalent to K182440 (A-1 Engineering, 2019) after a 597-day review. Its family tree reaches back 6 generations to 1994. 1 later device descends from it.
- Decided
- Oct 21, 2021
- Review
- 597 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K940301 (1994). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 5 generations backK011880 Compex SportCompex S.A. · 2002
- 4 generations backK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- 3 generations backK083140 Compex Sport PlusChattanooga Group · 2009
- 2 generations backK143551 Compex Wireless USADjo, LLC · 2015
- 1 generation backK182440 Body SystemA-1 Engineering · 2019
- This deviceK200545 Legend Pro DMAPollogen, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK233470 Deka LilyEl.En S.P.A. · 2023
Most influential descendants
Showing 1 of 1 · See all- K233470Deka LilyEl.En S.P.A. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −5 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −4 | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| −3 | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| −2 | K143551 | Compex Wireless USA | Djo, LLC | 2015 | — |
| −1 | K182440 | Body System | A-1 Engineering | 2019 | — |
| 0 (this device) | K200545 | Legend Pro DMA | Pollogen, Ltd. | 2021 | — |
| +1 | K233470 | Deka Lily | El.En S.P.A. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 NGX? 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 NGX device
- #1 K250146 SofWave Systemscore 15.5 · 12 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 |
|---|---|---|---|
| * | K182440 | Body SystemSummary page 4…NGX Device Class: Class II Regulation Number: 21 CFR 890.5850 Panel: Physical Medicine Predicate Device: Body System (K182440) Reference Device AK Body Toning Device (K152420) Intended Use/ Indications for Use: Legend Pro DMA is intended for m… | 2019 |
| † | K152420 | AK Body Toning Device | 2016 |
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 |
|---|---|---|---|
| K233470 | Deka Lily | 2023 | 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 27 years and passes through 7 companies; a new generation was cleared every 5.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K233470 (El.En S.P.A., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K182440.
How does its category compare?
All NGX devicesNGX Stimulator, Muscle, Powered, For Muscle Conditioning: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NGX
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGX
93in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGX
2in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NGX
15in 2025
MAUDE reports naming product code NGX, 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 | 7 | 135 | 0 | 0 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 4 | 132 | 0 | 0 |
| 2010 | 6 | 180 | 0 | 0 |
| 2011 | 5 | 291 | 0 | 1 |
| 2012 | 3 | 362 | 0 | 0 |
| 2013 | 6 | 269 | 2 | 1 |
| 2014 | 6 | 298 | 0 | 0 |
| 2015 | 9 | 184 | 0 | 7 |
| 2016 | 4 | 240 | 0 | 21 |
| 2017 | 10 | 108 | 0 | 2 |
| 2018 | 6 | 104 | 0 | 6 |
| 2019 | 14 | 167 | 0 | 4 |
| 2020 | 11 | 207 | 0 | 7 |
| 2021 | 12 | 256 | 0 | 5 |
| 2022 | 6 | 307 | 0 | 7 |
| 2023 | 12 | 96 | 0 | 8 |
| 2024 | 12 | 207 | 0 | 11 |
| 2025 | 15 | 93 | 0 | 15 |
| 2026 | 4 | 118 | 0 | — |
What is it indicated for?
Legend Pro DMA is intended for muscle conditioning to stimulate healthy muscles.
Legend Pro DMA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Legend Pro DMA is intended to be operated by a trained professional who is present to monitor treatment
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200545: Legend Pro DMA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200545
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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