510(k) · Cleared
Recalled · 2010RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive Garment , Model RS-FBG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rs Medical · GXY Electrode, Cutaneous
Cleared on Jun 5, 2009 as substantially equivalent to K013532 (Axelgaard Mfg. Co., Ltd., 2002) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Jun 5, 2009
- Review
- 63 days
- Class
- Class II
- Product code
- GXY
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000947 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000947 Ultrastim Electrode, Model US4040Axelgaard Mfg. Co., Ltd. · 2000
- This deviceK090951 RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG…Rs Medical · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000947 | Ultrastim Electrode, Model US4040 | Axelgaard Mfg. Co., Ltd. | 2000 | — |
| 0 (this device) | K090951 | RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back… | Rs Medical | 2009 | — |
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 |
|---|---|---|---|
| * | K013532 | Ultrastim KitSummary page 1…ack Conductive Garment and RS-FBG TMFull Back Conductive Garment are substantially equivalent to the Axelgaard Manufacturing Company, Ltd. UltraStime Kit (K013532) which include UltraStime Electrodes (K000947). 4. Indications for Use The RS Medical Conductive Garments and associated acc… | 2002 |
| * | K000947 | Ultrastim Electrode, Model US4040Summary page 1…l Back Conductive Garment are substantially equivalent to the Axelgaard Manufacturing Company, Ltd. UltraStime Kit (K013532) which include UltraStime Electrodes (K000947). 4. Indications for Use The RS Medical Conductive Garments and associated accessories are indicated for use with RS Medi… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2010 | Not classified | Z-2093-2010 | Other | Device distributed with labeling and IFU outside of their 510(k) clearance. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K013532.
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 RS Medical Conductive Garments and associated accessories are indicated for use with RS Medical Stimulators to facilitate electrode placement and maintenance of electrode positioning for stimulation treatments of the lower, middle and upper back.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090951 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090951: RS- LB Low Back Conductive Garment, Model RS-LBM, RS-LBL, RS-FBG Full Back Conductive Garment , Model RS-FBG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090951
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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