510(k) · Cleared
ClearedEtg 255 Combo Stimualtor, Ten 260 Stimualtor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Handelshaus Dittman GmbH · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Jul 29, 2011 as substantially equivalent to K060222 (Gemore Technology Co, Ltd., 2006) after a 168-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Jul 29, 2011
- Review
- 168 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040512 (2004). No later device cites it as a predicate yet.
- Root · 2 generations backK040512 Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A…Well-Life Healthcare, Inc. · 2004
- 1 generation backK060222 Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and…Gemore Technology Co, Ltd. · 2006
- This deviceK110390 Etg 255 Combo Stimualtor, Ten 260 StimualtorHandelshaus Dittman GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040512 | Limited Function WL/Otc-Tens Device, Model WL-2103A, WL-2203A, WL-2203B and… | Well-Life Healthcare, Inc. | 2004 | — |
| −1 | K060222 | Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PP | Gemore Technology Co, Ltd. | 2006 | — |
| 0 (this device) | K110390 | Etg 255 Combo Stimualtor, Ten 260 Stimualtor | Handelshaus Dittman GmbH | 2011 | — |
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 |
|---|---|---|---|
| * | K060222 | Low Back Pain Relief System /Models GM310PP,GM320PP,GM321PP, and GM330PPSummary page 2…Product Code: NUH Device Class: 11 2. Predicate Device: Predicate Device: Low Back Pain Relief System 510(k) Number: K060222 Manufacturer: Gemore Technology Co.,Ltd 3. Description of Proposed Device: Care back pain relief stimulator, whic… | 2006 |
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 7 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K060222.
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. 2011, 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?
Care back pain relief stimulator is intended for temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K110390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110390: Etg 255 Combo Stimualtor, Ten 260 Stimualtor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110390
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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