510(k) · Cleared
ClearedModification to:Kneehab XP Conductive Garment, Model 411
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · GXY Electrode, Cutaneous
Cleared on Dec 7, 2009 as substantially equivalent to K083105 (Bio-Medical Research, Ltd., 2009) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 7, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K912178 (1991). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 4 generations backK961376 Smart-Tens, Model 456Bio-Medical Research, Ltd. · 1996
- 3 generations backK023913 Neurotech Baxolve Type 294Bio-Medical Research, Ltd. · 2003
- 2 generations backK082190 Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models…Bio-Medical Research, Ltd. · 2009
- 1 generation backK091317 Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009
- This deviceK092793 Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −4 | K961376 | Smart-Tens, Model 456 | Bio-Medical Research, Ltd. | 1996 | — |
| −3 | K023913 | Neurotech Baxolve Type 294 | Bio-Medical Research, Ltd. | 2003 | — |
| −2 | K082190 | Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 | Bio-Medical Research, Ltd. | 2009 | — |
| −1 | K091317 | Lumbofix Conductive Garment, Model 420 Back | Bio-Medical Research, Ltd. | 2009 | — |
| 0 (this device) | K092793 | Modification to:Kneehab XP Conductive Garment, Model 411 | Bio-Medical Research, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 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 |
|---|---|---|---|
| * | K083105 | Kneehab XP Conductive Garment, Type 411Summary page 1…Kneehab XP Conductive Garment, Type 411 Manufacturer: Bio-Medical Research Ltd. 510(k) No: K083105 Name: Lumbofixtm Conductive Garment Manufacturer: Bio-Medical Researc… | 2009 |
| * | K091317 | Lumbofix Conductive Garment, Model 420 BackSummary page 1…Name: Lumbofixtm Conductive Garment Manufacturer: Bio-Medical Research Ltd. 5 10(k) No: K091317 4. Description of Device The proposed Kneebab XP Conductive Garment is an integrated thigh wrap garment designed to… | 2009 |
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 18 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 13 ancestors has a recall.
- 3 other devices also cite its predicate K083105.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The Neurotech Kneehab Conductive Garment and associated accessories are indicated for
use with Neurotech Stimulators to facilitate the frequent and correct positioning and
repositioning of large, multiple, and/or difficult to reach stimulation sites associated with
the quadriceps area of the leg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092793 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092793: Modification to:Kneehab XP Conductive Garment, Model 411.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092793
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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