510(k) · Cleared
ClearedSTIMPOD NMS460 Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xavant Technology (Pty), Ltd. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jan 18, 2017 as substantially equivalent to K081835 (Bioinduction Limited, 2009) and 1 other predicate after a 275-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.
- Decided
- Jan 18, 2017
- Review
- 275 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K882438 (1988). 20 ancestors in all, the oldest K872657 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK882438 Constant Current Peripheral Nerve Stim. #NS252Fisher & Paykel Healthcare, Ltd. · 1988
- 3 generations backK023342 Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable…Hdc Corp. · 2004
- 2 generations backK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- 1 generation backK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- This deviceK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK252712 STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK213802 StimOnTM Pain Relief System (GM2439)Gimer Medical Co., Ltd. · 2022
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 | K882438 | Constant Current Peripheral Nerve Stim. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988 | — |
| −3 | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii… | Hdc Corp. | 2004 | — |
| −2 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| −1 | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| 0 (this device) | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| +1 | K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026 | — |
| +1 | K213802 | StimOnTM Pain Relief System (GM2439) | Gimer Medical Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K081835 | Acticare IC and TseSummary page 4…NMS460 Nerve Stimulator is similar to the following predicate device as a TENS device under classification GZJ: Acticare (K081835), Bioinduction Ltd The STIMPOD NMS460 Nerve Stimulator mapping probe is similar to the following… | 2009 |
| * | K093591 | Stimpod Model NMS-400 Nerve StimulatorSummary page 4…be is similar to the following predicate device under classification BXN: STIMPOD NMS400 (K093591), Xavant Technology Description of the Device [21CFR807.92(a)(4)] The STIMPOD NMS460 Nerve Stimulator is a hand… | 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 29 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K252712 (Algiamed Technologies USA, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081835.
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. 2017, 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 STIMPOD NMS460 Nerve Stimulator is a Transcutaneous Electrical Nerve Stimulation (TENS) device used for
symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of
post-surgical pain, post traumatic acute pain problems, as well as an adjunct for pain control due to rehabilitation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161091 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161091: STIMPOD NMS460 Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161091
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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