510(k) · Cleared
ClearedAcu-Strap Motion Sickness Band
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Health Ent., Inc. · MVV Device, Acupressure
Cleared on Oct 8, 2004 as substantially equivalent to K033268 (Sea-Band UK, Ltd., 2004) after an 88-day review. Its family tree reaches back 6 generations to 1997. 7 later devices descend from it.
- Decided
- Oct 8, 2004
- Review
- 88 days
- Class
- Class U
- Product code
- MVV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961050 (1997). 9 ancestors in all, the oldest K900588 (1990). 7 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 5 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 4 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 3 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 2 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- 1 generation backK033268 Sea-BandSea-Band UK, Ltd. · 2004
- This deviceK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
- Descendant · cites it directly · 3 of its ownK051397 BiobandsBiobands Distributors, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK193374 TumEase Acupressure BraceletsMumease · 2020
- Descendant · cites it directly · 2 of its ownK053509 Acuband Acupressure Wrist Band DeviceAcuband, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK070766 Psi BandsPsi Health Solutions, Inc. · 2007 · Recalled
- Descendant · cites it directly · 0 of its ownK220289 FridaMom Anti-Nausea BandsFridababy, LLC · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K051397BiobandsBiobands Distributors, Inc. · 2005 · cites it directly3descendants
- K193374TumEase Acupressure BraceletsMumease · 2020 · cites it directly2descendants
- K053509Acuband Acupressure Wrist Band DeviceAcuband, Inc. · 2006 · cites it directly2descendants
- K070766Psi BandsPsi Health Solutions, Inc. · 2007 · 2 generations on1descendant
- K220289FridaMom Anti-Nausea BandsFridababy, LLC · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −5 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −4 | 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 | — |
| −2 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| −1 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| 0 (this device) | K041877 | Acu-Strap Motion Sickness Band | Health Ent., Inc. | 2004 | — |
| +1 | K051397 | Biobands | Biobands Distributors, Inc. | 2005 | — |
| +1 | K193374 | TumEase Acupressure Bracelets | Mumease | 2020 | — |
| +1 | K053509 | Acuband Acupressure Wrist Band Device | Acuband, Inc. | 2006 | — |
| +2 | K070766 | Psi Bands | Psi Health Solutions, Inc. | 2007 | 1 |
| +1 | K220289 | FridaMom Anti-Nausea Bands | Fridababy, LLC | 2022 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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? (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 |
|---|---|---|---|
| * | K033268 | Sea-BandSummary page 1…mined Neurology 3. PREDICATE DEVICES Acu-StrapTm Travel and Motion Sickness Band is substantially equivalent to the Sea- Band, 5 10(k) No. K033268. 4. DEVICE DESCRIPTION The Acu-StrapTm Travel and Motion Sickness Band product comprises a pair of wristband… | 2004 |
What descends from it? (7)
4 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 7 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K051397 (Biobands Distributors, Inc., 2005) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K033268.
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 Acu-Strap TM Travel and Motion Sickness Band is intended for the relief of nausea. Nausea may be experienced due to Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia or Chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041877 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041877: Acu-Strap Motion Sickness Band.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041877
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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