510(k) · Cleared
ClearedBaxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298
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 Mar 11, 2009 as substantially equivalent to K023913 (Bio-Medical Research, Ltd., 2003) and 1 other predicate after a 219-day review. Its family tree reaches back 3 generations to 1991. 4 later devices descend from it.
- Decided
- Mar 11, 2009
- Review
- 219 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K912178 (1991). 4 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK912178 Bio Tens 601, 606 and 608 (3000)Skylark Device Co., Ltd. · 1991
- 2 generations backK961376 Smart-Tens, Model 456Bio-Medical Research, Ltd. · 1996
- 1 generation backK023913 Neurotech Baxolve Type 294Bio-Medical Research, Ltd. · 2003
- This deviceK082190 Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models…Bio-Medical Research, Ltd. · 2009
- Descendant · cites it directly · 2 of its ownK091317 Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK112934 Neurotech RecoveryBio-Medical Research, Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK102614 Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK092793 Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd. · 2009
Most influential descendants
Showing 4 of 4 · See all- K091317Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009 · cites it directly2descendants
- K112934Neurotech RecoveryBio-Medical Research, Ltd. · 2012 · cites it directly0descendants
- K102614Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011 · 2 generations on0descendants
- K092793Modification to:Kneehab XP Conductive Garment, Model 411Bio-Medical Research, Ltd. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912178 | Bio Tens 601, 606 and 608 (3000) | Skylark Device Co., Ltd. | 1991 | — |
| −2 | K961376 | Smart-Tens, Model 456 | Bio-Medical Research, Ltd. | 1996 | — |
| −1 | K023913 | Neurotech Baxolve Type 294 | Bio-Medical Research, Ltd. | 2003 | — |
| 0 (this device) | 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 | — |
| +1 | K112934 | Neurotech Recovery | Bio-Medical Research, Ltd. | 2012 | — |
| +2 | K102614 | Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 | Bio-Medical Research, Ltd. | 2011 | — |
| +2 | 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 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K023913 | Neurotech Baxolve Type 294Summary page 1…rketed Device 1. Name: Neurotech Baxolve, Manufacturer: Bio-Medical Research Ltd 510(k) No: K023913 2. Name Ultrastim Kit Manufacturer: Axelgaard Mfg. Co. Ltd. 510(k) No:… | 2003 |
| * | K013532 | Ultrastim KitSummary page 1…K023913 2. Name Ultrastim Kit Manufacturer: Axelgaard Mfg. Co. Ltd. 510(k) No: K013532 Directors: T. Kirwan (Chairman), Dr. P. A. Smith (Managing), P.K. McDonnell, C. Minogue, P. McGrath.… | 2002 |
What descends from it? (4)
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 4 ancestors has a recall.
- Of its descendants, K091317 (Bio-Medical Research, Ltd., 2009) has gone furthest, with 2 descendants of its own.
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?
Type 297
Can be used on its own as a lumbar support device or as a conductive garment for use 'with cleared Transcutaneous Electrical Nerve Stimulation (TENS) devices for the following:
* The symptomatic relief and management of chronic and intractable pain in the lower back region.
- Assists in correctly positioning and repositioning pads on difficult to reach locations of the lower back
* Lumbar support
Type 298
Can be used on its own as a lumbar support device only:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082190: Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082190
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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