510(k) · Cleared
ClearedFirefly
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Firstkind Limited · NGX Stimulator, Muscle, Powered, For Muscle Conditioning
Cleared on May 15, 2014 as substantially equivalent to K083140 (Chattanooga Group, 2009) after a 139-day review. Its family tree reaches back 4 generations to 1994. 1 later device descends from it.
- Decided
- May 15, 2014
- Review
- 139 days
- Class
- Class II
- Product code
- NGX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K940301 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 3 generations backK011880 Compex SportCompex S.A. · 2002
- 2 generations backK061632 Globus Premium Muscle StimulatorDomino S.R.L. · 2007
- 1 generation backK083140 Compex Sport PlusChattanooga Group · 2009
- This deviceK134001 FireflyFirstkind Limited · 2014
- Descendant · cites it directly · 0 of its ownK201131 firefly T-2Firstkind Limited · 2020
Most influential descendants
Showing 1 of 1 · See all- K201131firefly T-2Firstkind Limited · 2020 · cites it directly0descendants
View 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 | K061632 | Globus Premium Muscle Stimulator | Domino S.R.L. | 2007 | — |
| −1 | K083140 | Compex Sport Plus | Chattanooga Group | 2009 | — |
| 0 (this device) | K134001 | Firefly | Firstkind Limited | 2014 | — |
| +1 | K201131 | firefly T-2 | Firstkind Limited | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K083140 | Compex Sport PlusSummary page 1…CFR 890.5850, Class 11 Product Code: NGX Panel: 89, Physical Medicine D. Predicate Device: Compex® Sport Plus (K083140) E. Device Description: The firefly TM T-1 device is a disposable, fully integrated neuromuscular stimulator for musc… | 2009 |
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 |
|---|---|---|---|
| K201131 | firefly T-2 | 2020 | 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 20 years and passes through 5 companies; a new generation was cleared every 5.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K201131 (Firstkind Limited, 2020) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K083140.
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. 2014, 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 firefly™ T-1 device is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The firefly™ T-1 device is not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134001 · printed Nov 6, 2026
Cite this page
510(k) Report. “K134001: Firefly.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K134001
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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