510(k) · Cleared
ClearedLumbofix Conductive Garment, Model 420 Back
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jun 25, 2009 as substantially equivalent to K082190 (Bio-Medical Research, Ltd., 2009) after a 52-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Jun 25, 2009
- Review
- 52 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K912178 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 3 generations backK961376 Smart-Tens, Model 456Bio-Medical Research, Ltd. · 1996
- 2 generations backK023913 Neurotech Baxolve Type 294Bio-Medical Research, Ltd. · 2003
- 1 generation backK082190 Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models…Bio-Medical Research, Ltd. · 2009
- This deviceK091317 Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK102614 Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK092793 Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −3 | K961376 | Smart-Tens, Model 456 | Bio-Medical Research, Ltd. | 1996 | — |
| −2 | K023913 | Neurotech Baxolve Type 294 | Bio-Medical Research, Ltd. | 2003 | — |
| −1 | K082190 | Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 | Bio-Medical Research, Ltd. | 2009 | — |
| 0 (this device) | K091317 | Lumbofix Conductive Garment, Model 420 Back | Bio-Medical Research, Ltd. | 2009 | — |
| +1 | K102614 | Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 | Bio-Medical Research, Ltd. | 2011 | — |
| +1 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 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 |
|---|---|---|---|
| * | K082190 | Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298Summary page 1…& Lumbar Support Kit Manufacturer: Bio-Medical Research Ltd 510(k) No: K082190 4. Description of Device The Lumbofix® Conductive Garment is a conductive garment intended for use in conjunction w… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K102614 (Bio-Medical Research, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K082190.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Lumbofix® Conductive Garment provides symptomatic relief and management of chronic and intractable pain in the lower back region and assists in the frequent and correct positioning and repositioning of pads on difficult to reach and/or large locations of the lower back.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091317: Lumbofix Conductive Garment, Model 420 Back.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091317
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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