510(k) · Cleared
ClearedSea-Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sea-Band UK, Ltd. · MVV Device, Acupressure
Cleared on Jan 7, 2004 as substantially equivalent to K900588 (Euro-Am Pharma, Inc., 1990) and 6 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1997. 10 later devices descend from it.
- Decided
- Jan 7, 2004
- Review
- 90 days
- Class
- Class U
- Product code
- MVV
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K961050 (1997). 8 ancestors in all, the oldest K900588 (1990). 10 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 4 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 3 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 2 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 1 generation backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- This deviceK033268 Sea-BandSea-Band UK, Ltd. · 2004
- Descendant · cites it directly · 7 of its ownK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
- Descendant · cites it directly · 4 of its ownK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
- Descendant · cites it directly · 3 of its ownK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK051397 BiobandsBiobands Distributors, Inc. · 2005
- Descendant · 2 generations on · 2 of its ownK193374 TumEase Acupressure BraceletsMumease · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K041877Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004 · cites it directly7descendants
- K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist StripTherapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011 · cites it directly4descendants
- K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist StripPressure Point, Inc. · 2014 · cites it directly3descendants
- K051397BiobandsBiobands Distributors, Inc. · 2005 · cites it directly3descendants
- K193374TumEase Acupressure BraceletsMumease · 2020 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −4 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −3 | 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 | — |
| −1 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| 0 (this device) | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| +1 | K041877 | Acu-Strap Motion Sickness Band | Health Ent., Inc. | 2004 | — |
| +1 | K110563 | Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management… | Therapeutics 101, Inc (Dba Pressure Point, Inc.) | 2011 | — |
| +1 | K142471 | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist… | Pressure Point, Inc. | 2014 | — |
| +1 | K051397 | Biobands | Biobands Distributors, Inc. | 2005 | — |
| +2 | K193374 | TumEase Acupressure Bracelets | Mumease | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 MVV? 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 MVV device
- #1 K193374 TumEase Acupressure Braceletsscore 7.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (18)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900588 | Acu-Band Accupressure Wrist BandSummary page 3…2002. Product Code See Classification Name above IDENTIFICATION OF PREDICATE DEVICE Substantial Equivalence to Acu-Band K900588 The Sea-Band manufactured by Sea-Band Ltd is substantially equivalent to the Acu-Band by Euro Am Pharma Inc.… | 1990 |
| * | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RLSummary page 3…d Ltd "Sea-Band" is also substantially equivalent to various "Relief Band" products manufactured by Woodside Biomedical, Inc. K Number Product K020180 ReliefBand® Device Models RB-DL, RB-EL and RB-RL K994387 ReliefBand® Device Models WB-2L,… | 2002 |
| * | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RLSummary page 3…anufactured by Woodside Biomedical, Inc. K Number Product K020180 ReliefBand® Device Models RB-DL, RB-EL and RB-RL K994387 ReliefBand® Device Models WB-2L, WB-6L, and WB-RL(Rx) K983907 ReliefBand® NSTTM Device Mo… | 2000 |
| * | K983907 | Reliefband NST Device Models WB-2,WB-6,WB-RSummary page 3…liefBand® Device Models RB-DL, RB-EL and RB-RL K994387 ReliefBand® Device Models WB-2L, WB-6L, and WB-RL(Rx) K983907 ReliefBand® NSTTM Device Models WB-2L K982967 ReliefBand® Device Models RB-2, RB-… | 1999 |
| * | K982967 | Reliefband MST Device, Models RB-2, RB-6, RB-RSummary page 3…87 ReliefBand® Device Models WB-2L, WB-6L, and WB-RL(Rx) K983907 ReliefBand® NSTTM Device Models WB-2L K982967 ReliefBand® Device Models RB-2, RB- 6 and RB-R (OTC) K982436 ReliefBand® Device Models W… | 1999 |
| * | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RSummary page 3…07 ReliefBand® NSTTM Device Models WB-2L K982967 ReliefBand® Device Models RB-2, RB- 6 and RB-R (OTC) K982436 ReliefBand® Device Models WB-2, WB-6, WB-R K980333 ReliefBand®Device Model SW-i 11… | 1998 |
| * | K980333 | ReliefbandSummary page 3…ReliefBand® Device Models RB-2, RB- 6 and RB-R (OTC) K982436 ReliefBand® Device Models WB-2, WB-6, WB-R K980333 ReliefBand®Device Model SW-i 11 Substantial Equivalence to Other Products Other similar products to the Sea-Ba… | 1998 |
| Kept off the family tree | K822306 | FDA’s K822306 is Bio-Band Bandages Our reading of the summary gave K822306, FDA’s number for Bio-Band Bandages (Robert Hirschfield). Its FDA name has none of the distinctive words the summary uses for the device it names, “BioBands”. Kept off the family tree. Summary page 4…TRAVELGARDE Acupressure Wrist Band Marine Logic Inc. 400 Australian Ave. Suite 725 West Palm Beach FL 33401 Tel 407 832 5112 Made in USA BioBands - Morning Sickness - K822306 BioBands Inc. NY 10010 Patent 5078728 Made in USA MedicMates - Anti Sickness Bands for sea travel and morning sickness MedicMate… | 1984 |
| * | — | Travel Smart by Victor Kiam - NoQweez Motion Discomfort Wrist Bands Named without a submission number | |
| * | — | Travel Band Named without a submission number | |
| * | — | Valet - Travelaide Wristbands Named without a submission number | |
| * | — | First Aid - Ezy Traveler Wristband Named without a submission number | |
| * | — | Davis - QUEAZ-AWAY Travelers' Wristbands Named without a submission number | |
| * | — | Accu-Presure BANDS Named without a submission number | |
| * | — | Rissband Named without a submission number | |
| * | — | TRAVELGARDE Acupressure Wrist Band Named without a submission number | |
| * | — | MedicMates - Anti Sickness Bands Named without a submission number | |
| * | — | The Traveleze Named without a submission number |
What descends from it? (10)
7 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041877 | Acu-Strap Motion Sickness Band | 2004 | 7 |
| K110563 | Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip | 2011 | 4 |
| K142471 | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip | 2014 | 3 |
| K051397 | Biobands | 2005 | 3 |
| K053509 | Acuband Acupressure Wrist Band Device | 2006 | 2 |
| K211823 | Bonine Acupressure Bands | 2021 | 0 |
| K110821 | Barf Band | 2012 | 0 |
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 1.4 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K041877 (Health Ent., Inc., 2004) has gone furthest, with 7 descendants of its own.
How does its category compare?
All MVV devicesMVV Device, Acupressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MVV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MVV
Too few MVV 510(k)s in any year since 2007 to give a median.
Recalls per year · MVV
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MVV
1in 2024
MAUDE reports naming product code MVV, 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 | 1 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sea-Band Limited "Sea-Band" is indicated for the relief of nausea.
(Nausea is a symptom that may be experienced due to a variety of causes, for example:
• Travel/Motion
- Pregnancy (Morning Sickness)
* Chemotherapy
- Post Operative)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033268 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033268: Sea-Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033268
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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