510(k) · Cleared
ClearedAvivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40
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 Jun 3, 2011 as substantially equivalent to K091317 (Bio-Medical Research, Ltd., 2009) after a 266-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 3, 2011
- Review
- 266 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912178 (1991). 6 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 deviceK102614 Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011
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) | K102614 | Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 | Bio-Medical Research, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K091317 | Lumbofix Conductive Garment, Model 420 BackSummary page 1…Lumbofix Conductive Garment, Type 420 Back Manufacturer: Bio-Medical Research Ltd 5 10(k) No: K091317 Device Trade Name: Kneehab XP Conductive Garment, Type 411 Manufacturer:… | 2009 |
| * | — | Kneehab XP Conductive Garment, Type 411 Named without a submission number |
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 20 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K091317.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place. The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back…
Read the full statement (201 words)
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.
The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee.
The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder.
The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices 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 shoulder, knee and upper back (cervical) areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102614: Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102614
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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