510(k) · Cleared
ClearedReliefband
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Woodside Biomedical, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on Feb 18, 1998 as substantially equivalent to K961050 (Maven Labs, Inc., 1997) after a 21-day review. Its family tree reaches back 1 generation to 1997. 20 later devices descend from it.
- Decided
- Feb 18, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K961050 (1997). 20 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- This deviceK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- Descendant · cites it directly · 19 of its ownK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- Descendant · 2 generations on · 18 of its ownK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- Descendant · 3 generations on · 17 of its ownK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK033268 Sea-BandSea-Band UK, Ltd. · 2004
- Descendant · 2 generations on · 7 of its ownK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998 · cites it directly19descendants
- K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000 · 2 generations on18descendants
- K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002 · 3 generations on17descendants
- K033268Sea-BandSea-Band UK, Ltd. · 2004 · cites it directly10descendants
- K041877Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| 0 (this device) | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| +1 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| +2 | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000 | — |
| +3 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| +1 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| +2 | K041877 | Acu-Strap Motion Sickness Band | Health Ent., Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 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 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 |
|---|---|---|---|
| * | K961050 | Reliefband Tens Unit (Modification)Summary page 1…and b. Classification: Class II c. Product Code: 73BWK 19.3 IDENTIFICATION OF PREDICATE DEVICE Device Manufacturer 510(k) No. Date Cleared ReliefBand Maven Laboratories K961050 August 1, 1997 JANUARY 26, 1998 144 [ WOODSIDE BIOMEDICAL, INC. RELIEFBAND® 510K 19.4 DEVICE DESCRIPTION The… | 1997 |
What descends from it? (20)
See all 202 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?
- Its one ancestor has no recall.
- Of its descendants, K982436 (Woodside Biomedical, Inc., 1998) has gone furthest, with 19 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?
The ReliefBand is indicated for use in the treatment of nausea and vomiting (NV) due to chemotherapy, motion sickness, and pregnancy.
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/K980333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980333: Reliefband.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980333
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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