510(k) · Cleared
ClearedUltrastim Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axelgaard Mfg. Co., Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 22, 2002 after a 309-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Aug 22, 2002
- Review
- 309 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK013532 Ultrastim KitAxelgaard Mfg. Co., Ltd. · 2002
- Descendant · cites it directly · 4 of its ownK082190 Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models…Bio-Medical Research, Ltd. · 2009
- Descendant · 2 generations on · 2 of its ownK091317 Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK133502 5000Z Firefly SystemPrizm Medical, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK112934 Neurotech RecoveryBio-Medical Research, Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK102614 Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082190Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298Bio-Medical Research, Ltd. · 2009 · cites it directly4descendants
- K091317Lumbofix Conductive Garment, Model 420 BackBio-Medical Research, Ltd. · 2009 · 2 generations on2descendants
- K1335025000Z Firefly SystemPrizm Medical, Inc. · 2014 · cites it directly0descendants
- K112934Neurotech RecoveryBio-Medical Research, Ltd. · 2012 · 2 generations on0descendants
- K102614Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40Bio-Medical Research, Ltd. · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013532 | Ultrastim Kit | Axelgaard Mfg. Co., Ltd. | 2002 | — |
| +1 | K082190 | Baxolve XP Conductive Garment Accessory & Lumbar Support Kit, Models 297, 298 | Bio-Medical Research, Ltd. | 2009 | — |
| +2 | K091317 | Lumbofix Conductive Garment, Model 420 Back | Bio-Medical Research, Ltd. | 2009 | — |
| +1 | K133502 | 5000Z Firefly System | Prizm Medical, Inc. | 2014 | — |
| +2 | K112934 | Neurotech Recovery | Bio-Medical Research, Ltd. | 2012 | — |
| +3 | K102614 | Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 | Bio-Medical Research, Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 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?
- Of its descendants, K082190 (Bio-Medical Research, Ltd., 2009) has gone furthest, with 4 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.
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 UltraStim Kit is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013532: Ultrastim Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013532
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026