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 Oct 7, 2022 as substantially equivalent to K201975 (Miha Bodytec GmbH, 2021) and 1 other predicate after a 137-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Oct 7, 2022
- Review
- 137 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K881114 (1988). 36 ancestors in all, the oldest K872976 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK881114 Empi Model 989, TensEmpi · 1988
- 7 generations backK970203 Epix VTEmpi · 1997
- 6 generations backK061650 Select Tens, Model 4600SEmpi · 2007
- 5 generations backK093324 Empi ContinuumEmpi · 2010
- 4 generations backK124016 Empi PhoenixDjo, LLC · 2013
- 3 generations backK153704 StriveDjo, LLC · 2016
- 2 generations backK170903 Compex Wireless USADjo, LLC · 2017
- 1 generation backK190966 Katalyst Training SystemKatalyst, Inc. · 2020
- This deviceK221498 Miha Bodytec IIMiha Bodytec GmbH · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K881114 | Empi Model 989, Tens | Empi | 1988 | — |
| −7 | K970203 | Epix VT | Empi | 1997 | — |
| −6 | K061650 | Select Tens, Model 4600S | Empi | 2007 | — |
| −5 | K093324 | Empi Continuum | Empi | 2010 | — |
| −4 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| −3 | K153704 | Strive | Djo, LLC | 2016 | — |
| −2 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| −1 | K190966 | Katalyst Training System | Katalyst, Inc. | 2020 | — |
| 0 (this device) | K221498 | Miha Bodytec II | Miha Bodytec GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K201975 | 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, K201975 Secondary: Katalyst Training System, K190966 Intended Use miha bodytec II is a device which performs ele… | 2021 |
| * | K190966 | Katalyst Training SystemSummary page 4…850, Product Code NGX and IPF) Predicate Device Predicate Device: Primary: miha bodytec II, K201975 Secondary: Katalyst Training System, K190966 Intended Use miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. The device is spe… | 2020 |
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 34 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 36 ancestors has a recall of any class.
- 1 other device also cites its predicate K201975.
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. 2022, 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 is a device which performs electronic muscle stimulation based on EMS technology. 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…
Read the full statement (159 words)
miha bodytec II is a device which performs electronic muscle stimulation based on EMS technology. 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 of motoneurons 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.
miha bodytec II may only be used by persons above the age of 21.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221498: 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/K221498
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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