510(k) · Cleared
Clearedmiha bodytec II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miha Bodytec GmbH · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Mar 11, 2021 as substantially equivalent to K182519 (Miha Bodytec GmbH, 2019) and 1 other predicate after a 238-day review. Its family tree reaches back 4 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 11, 2021
- Review
- 238 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K940301 (1994). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK133225 E-Fit EF-1280 Ems MachineFit-Pro Kft, Ltd. · 2014
- 1 generation backK182519 Miha Bodytec IIMiha Bodytec GmbH · 2019
- This deviceK201975 miha bodytec IIMiha Bodytec GmbH · 2021
- Descendant · cites it directly · 0 of its ownK223797 Neuro20 Pro SystemNeuro20 Technologies · 2023
- Descendant · cites it directly · 0 of its ownK221498 Miha Bodytec IIMiha Bodytec GmbH · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −3 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −2 | K133225 | E-Fit EF-1280 Ems Machine | Fit-Pro Kft, Ltd. | 2014 | — |
| −1 | K182519 | Miha Bodytec II | Miha Bodytec GmbH | 2019 | — |
| 0 (this device) | K201975 | miha bodytec II | Miha Bodytec GmbH | 2021 | — |
| +1 | K223797 | Neuro20 Pro System | Neuro20 Technologies | 2023 | — |
| +1 | K221498 | Miha Bodytec II | Miha Bodytec GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K182519 | Miha Bodytec IISummary page 4…Stimulator, Muscle, Powered (21 CFR 890.5850, Product Code NGX and IPF) Predicate Device Predicate Device: Primary: miha bodytec II, K182519 Secondary: Compex rehab, K090632 Intended Use miha bodytec II is a machine with electronic muscle stimul… | 2019 |
| * | K090632 | Compex RehabSummary page 4…21 CFR 890.5850, Product Code NGX and IPF) Predicate Device Predicate Device: Primary: miha bodytec II, K182519 Secondary: Compex rehab, K090632 Intended Use miha bodytec II is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the dev… | 2009 |
What descends from it? (2)
2 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?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K223797 (Neuro20 Technologies, 2023) has gone furthest, with 0 descendants of its own.
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?
miha bodytec II (MBT II) is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions: * Re-educating muscles * Relaxation of muscle spasm * Retarding or preventing disuse…
Read the full statement (148 words)
miha bodytec II (MBT II) is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles.
miha bodytec II is intended to stimulate muscles in order to improve or facilitate muscle performance. In addition it is indicated for the following conditions:
* Re-educating muscles
* Relaxation of muscle spasm
* Retarding or preventing disuse muscle atrophy
The miha bodytec II electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations ofmotoneurons are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201975: miha bodytec II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201975
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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