510(k) · Cleared
ClearedGlobus Premium Muscle Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Domino S.R.L. · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on Apr 30, 2007 as substantially equivalent to K011880 (Compex S.A., 2002) after a 322-day review. Its family tree reaches back 2 generations to 1994. 40 later devices descend from it.
- Decided
- Apr 30, 2007
- Review
- 322 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K940301 (1994). 40 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 1 generation backK011880 Compex SportCompex S.A. · 2002
- This deviceK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- Descendant · cites it directly · 39 of its ownK083140 Compex Sport PlusChattanooga Group · 2009
- Descendant · 2 generations on · 20 of its ownK143551 Compex Wireless USADjo, LLC · 2015
- Descendant · 3 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 3 generations on · 5 of its ownK182440 Body SystemA-1 Engineering · 2019
- Descendant · 2 generations on · 4 of its ownK170918 Compex Sport EliteDjo, LLC · 2017
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K083140Compex Sport PlusChattanooga Group · 2009 · cites it directly39descendants
- K143551Compex Wireless USADjo, LLC · 2015 · 2 generations on20descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 3 generations on10descendants
- K182440Body SystemA-1 Engineering · 2019 · 3 generations on5descendants
- K170918Compex Sport EliteDjo, LLC · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −1 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| 0 (this device) | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| +1 | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| +2 | K143551 | Compex Wireless USA | Djo, LLC | 2015 | — |
| +3 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +3 | K182440 | Body System | A-1 Engineering | 2019 | — |
| +2 | K170918 | Compex Sport Elite | Djo, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K011880 | Compex SportSummary page 1…al Name: Electric Muscle Stimulator Classification Name: Powered muscle stimulator 3. PREDICATE DEVICES Compex Sport Stimulator Device K011880 4. DEVICE DESCRIPTION The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each dev… | 2002 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083140 | Compex Sport Plus | 2009 | 39 |
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 13 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K083140 (Chattanooga Group, 2009) has gone furthest, with 39 descendants of its own.
- 11 other devices also cite its predicate K011880.
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. 2007, 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?
The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061632: Globus Premium Muscle Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061632
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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