510(k) · Cleared
ClearedGlobus Genesy 1100 Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Domino S.R.L. · IPF Stimulator, Muscle, Powered
Cleared on Sep 21, 2007 as substantially equivalent to K031077 (Chattanooga Group, 2003) after a 121-day review. Its family tree reaches back 1 generation to 2003. 29 later devices descend from it.
- Decided
- Sep 21, 2007
- Review
- 121 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031077 (2003). 29 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK031077 Vectra Epr System and Intelect Epr SystemChattanooga Group · 2003 · Recalled
- This deviceK071431 Globus Genesy 1100 StimulatorDomino S.R.L. · 2007
- Descendant · cites it directly · 28 of its ownK090632 Compex RehabChattanooga Group · 2009
- Descendant · 2 generations on · 25 of its ownK124016 Empi PhoenixDjo, LLC · 2013
- Descendant · 3 generations on · 24 of its ownK153704 StriveDjo, LLC · 2016
- Descendant · 4 generations on · 10 of its ownK170903 Compex Wireless USADjo, LLC · 2017
- Descendant · 4 generations on · 7 of its ownK182203 JKH Stimulator PlusJkh USA, LLC · 2019
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K090632Compex RehabChattanooga Group · 2009 · cites it directly28descendants
- K124016Empi PhoenixDjo, LLC · 2013 · 2 generations on25descendants
- K153704StriveDjo, LLC · 2016 · 3 generations on24descendants
- K170903Compex Wireless USADjo, LLC · 2017 · 4 generations on10descendants
- K182203JKH Stimulator PlusJkh USA, LLC · 2019 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031077 | Vectra Epr System and Intelect Epr System | Chattanooga Group | 2003 | 17 |
| 0 (this device) | K071431 | Globus Genesy 1100 Stimulator | Domino S.R.L. | 2007 | — |
| +1 | K090632 | Compex Rehab | Chattanooga Group | 2009 | — |
| +2 | K124016 | Empi Phoenix | Djo, LLC | 2013 | — |
| +3 | K153704 | Strive | Djo, LLC | 2016 | — |
| +4 | K170903 | Compex Wireless USA | Djo, LLC | 2017 | — |
| +4 | K182203 | JKH Stimulator Plus | Jkh USA, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 2 | 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 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 19.6 · 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 |
|---|---|---|---|
| * | K031077 | Vectra Epr System and Intelect Epr SystemSummary page 1…nterferential Current Therapy Stimulator (IFC). 3. PREDICATE DEVICES Chattanooga Vectra GENiSYS Stimulator Device K031077 4. DEVICE DESCRIPTION The Globus Genesy Device is a programmable electro stimulator with multiple uses: Powered… | 2003 |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090632 | Compex Rehab | 2009 | 28 |
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?
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following: Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Maintaining or increasing range of motion…
Read the full statement (96 words)
The Globus Genesy 1100 Electro-stimulator should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions. It is intended to be used for therapies employing NMES, Russian, and Premodulated Currents (IFC) to obtain the following:
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Additional Indications for Microcurrent, Premodulated Currents (IFC), NMES and TENS waveforms:
Management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain
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/K071431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071431: Globus Genesy 1100 Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071431
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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