510(k) · Cleared
ClearedReliefband Tens Unit (Modification)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maven Labs, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Aug 1, 1997 after a 540-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 21 later devices descend from it.
- Decided
- Aug 1, 1997
- Review
- 540 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 1 citing it directly.
- This deviceK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- Descendant · cites it directly · 20 of its ownK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- Descendant · 2 generations on · 19 of its ownK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- Descendant · 3 generations on · 18 of its ownK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- Descendant · 4 generations on · 17 of its ownK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- Descendant · 2 generations on · 10 of its ownK033268 Sea-BandSea-Band UK, Ltd. · 2004
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K980333ReliefbandWoodside Biomedical, Inc. · 1998 · cites it directly20descendants
- K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998 · 2 generations on19descendants
- K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000 · 3 generations on18descendants
- K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002 · 4 generations on17descendants
- K033268Sea-BandSea-Band UK, Ltd. · 2004 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| +1 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| +2 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| +3 | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000 | — |
| +4 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| +2 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (21)
See all 211 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980333 | Reliefband | 1998 | 20 |
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?
- Of its descendants, K980333 (Woodside Biomedical, Inc., 1998) has gone furthest, with 20 descendants of its own.
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.
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?
To reduce the frequency of nausea and vomiting due to chemotherapy, motion sickness, and pregnancy.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961050 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961050: Reliefband Tens Unit (Modification).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961050
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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