510(k) · Cleared
ClearedAemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aemed, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Mar 13, 2008 as substantially equivalent to K032994 (Gemore Technology Co, Ltd., 2003) and 2 other predicates after a 328-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 328 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K913522 (1991). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK913522 Solitens ModifiedInnovative Designer Products, Inc. · 1991
- 1 generation backK982961 MedipointMedipoint, Ltd. · 1999
- This deviceK071120 Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator…Aemed, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK142686 StimPad OTCAemed, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK090866 Neurocalm Model 1 and 2Neuromed Devices, Inc. · 2009
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 |
|---|---|---|---|---|---|
| −2 | K913522 | Solitens Modified | Innovative Designer Products, Inc. | 1991 | — |
| −1 | K982961 | Medipoint | Medipoint, Ltd. | 1999 | — |
| 0 (this device) | K071120 | Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999 | Aemed, Inc. | 2008 | — |
| +1 | K142686 | StimPad OTC | Aemed, Inc. | 2014 | — |
| +1 | K090866 | Neurocalm Model 1 and 2 | Neuromed Devices, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 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? (3)
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 |
|---|---|---|---|
| * | K032994 | GM3 Series HV Tens, Model GM3X3HV (Where X IS Parameter of Different Housing)Summary page 2…substantially equivalent to the Gemore Technology Company Limited GM3 Series HV (High Voltage) TENS Model GM3X3HV (or equivalent GM323HV) cleared via 510(k) K032994, and to the Innovative Designer Products Inc. Solitens Modified cleared via 510(k) K913522 and to the Medipoint Micro… | 2003 |
| * | K913522 | Solitens ModifiedSummary page 2…ENS Model GM3X3HV (or equivalent GM323HV) cleared via 510(k) K032994, and to the Innovative Designer Products Inc. Solitens Modified cleared via 510(k) K913522 and to the Medipoint Microcurrent Therapy device cleared via K982961. The basic design features of StimPadTM are simi… | 1991 |
| * | K982961 | MedipointSummary page 2…and to the Innovative Designer Products Inc. Solitens Modified cleared via 510(k) K913522 and to the Medipoint Microcurrent Therapy device cleared via K982961. The basic design features of StimPadTM are similar to the predicate devices. The StimPnadTM device and each of the p… | 1999 |
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 17 years and passes through 3 companies; a new generation was cleared every 8.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142686 (Aemed, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032994.
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. 2008, 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 StimPadTM TENS System is indicated for the symptomatic relief of chronic intractable pain, and post-traumatic acute pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071120 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071120: Aemed Stimpad Acu-Tens Transcutaneous Electrical Nerve Stimulator, Model 021999.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071120
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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