510(k) · Cleared
ClearedSTIMPOD NMS460 Nerve Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Algiamed Technologies USA, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 28, 2026 as substantially equivalent to K161091 (Xavant Technology (Pty), Ltd., 2017) after a 274-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- May 28, 2026
- Review
- 274 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K882438 (1988). 21 ancestors in all, the oldest K872657 (1987). No later device cites it as a predicate yet.
- Root · 5 generations backK882438 Constant Current Peripheral Nerve Stim. #NS252Fisher & Paykel Healthcare, Ltd. · 1988
- 4 generations backK023342 Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable…Hdc Corp. · 2004
- 3 generations backK072092 Xpod/Xmap Nerve StimulatorXavant Technology (Pty), Ltd. · 2007
- 2 generations backK093591 Stimpod Model NMS-400 Nerve StimulatorXavant Technology (Pty), Ltd. · 2009
- 1 generation backK161091 STIMPOD NMS460 Nerve StimulatorXavant Technology (Pty), Ltd. · 2017
- This deviceK252712 STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K882438 | Constant Current Peripheral Nerve Stim. #NS252 | Fisher & Paykel Healthcare, Ltd. | 1988 | — |
| −4 | K023342 | Neuro-Trace Iii Kit, Neuro-Trace Iii Regional Block Cable, Neuro-Trace Iii… | Hdc Corp. | 2004 | — |
| −3 | K072092 | Xpod/Xmap Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2007 | — |
| −2 | K093591 | Stimpod Model NMS-400 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2009 | — |
| −1 | K161091 | STIMPOD NMS460 Nerve Stimulator | Xavant Technology (Pty), Ltd. | 2017 | — |
| 0 (this device) | K252712 | STIMPOD NMS460 Nerve Stimulator | Algiamed Technologies USA, Inc. | 2026 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K161091 | STIMPOD NMS460 Nerve StimulatorSummary page 5…del Name STIMPOD NMS460 Nerve Stimulator Manufacturer Xavant Technology (Pty) Ltdt Submission Number K161091 Classification Name Transcutaneous Electrical Nerve Stimulator (21 CFR 882.… | 2017 |
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 38 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 21 ancestors has a recall.
- 1 other device also cites its predicate K161091.
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. 2026, 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 conditions.
The device is also used as an adjunctive treatment in the management of post-surgical pain, post traumatic acute pain
problems, as well as adjunct for pain control due to rehabilitation.
The device provides temporary relief of mild to moderate neuropathic pain associated with diabetic peripheral neuropathy
of the lower extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252712: STIMPOD NMS460 Nerve Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252712
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026