510(k) · Cleared
ClearedAmd 6605 Tens/Nmes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advantageous Medical Devices, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Oct 23, 2009 as substantially equivalent to K032954 (Danmeter A/S, 2004) after a 25-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Oct 23, 2009
- Review
- 25 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032954 (2004). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK032954 Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Danmeter A/S · 2004
- This deviceK092990 Amd 6605 Tens/NmesAdvantageous Medical Devices, LLC · 2009
- Descendant · cites it directly · 1 of its ownK151922 StimSox (TM) SystemStimmed, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK171071 StimSox (TM) SystemStimmed, LLC · 2017
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 |
|---|---|---|---|---|---|
| −1 | K032954 | Elpha, Models II 500, II 1000, II 2000, II 3000 and E80 | Danmeter A/S | 2004 | — |
| 0 (this device) | K092990 | Amd 6605 Tens/Nmes | Advantageous Medical Devices, LLC | 2009 | — |
| +1 | K151922 | StimSox (TM) System | Stimmed, LLC | 2016 | — |
| +2 | K171071 | StimSox (TM) System | Stimmed, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K032954 | Elpha, Models II 500, II 1000, II 2000, II 3000 and E80Summary page 2…age 2 === Predicate Device Identification: 21CFR:890.5850 Product Code: IPFIGZJ Device Class: II Legally Marketed Device: Elpha 11 3000 Manufacturer: Danmeter A/S K#: K032954 Device Description: AMD 6605 TENS portion: is designed to provide electrical stimulation, for the following: · Symptomatic re… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151922 | StimSox (TM) System | 2016 | 1 |
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?
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. 2009, 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?
Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain
Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increasing local blood circulation
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092990 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092990: Amd 6605 Tens/Nmes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092990
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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