510(k) · Cleared
ClearedBiobands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biobands Distributors, Inc. · MVV Device, Acupressure
Cleared on Sep 16, 2005 as substantially equivalent to K033268 (Sea-Band UK, Ltd., 2004) and 1 other predicate after a 112-day review. Its family tree reaches back 7 generations to 1997. 3 later devices descend from it.
- Decided
- Sep 16, 2005
- Review
- 112 days
- Class
- Class U
- Product code
- MVV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K961050 (1997). 10 ancestors in all, the oldest K900588 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 6 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 5 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 4 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 3 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- 2 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
- 1 generation backK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
- This deviceK051397 BiobandsBiobands Distributors, Inc. · 2005
- 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 · 3 generations on · 0 of its ownK110821 Barf BandDoodlebug Products, LLC · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −6 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −5 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| −4 | 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 | — |
| −2 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| −1 | K041877 | Acu-Strap Motion Sickness Band | Health Ent., Inc. | 2004 | — |
| 0 (this device) | K051397 | Biobands | Biobands Distributors, Inc. | 2005 | — |
| +1 | K053509 | Acuband Acupressure Wrist Band Device | Acuband, Inc. | 2006 | — |
| +2 | K070766 | Psi Bands | Psi Health Solutions, Inc. | 2007 | 1 |
| +3 | K110821 | Barf Band | Doodlebug Products, LLC | 2012 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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? (2)
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…epa~ration Date oi May 18, 2005 Device Trade Name o BioBands Classification Name o Acu-pressure Device Legally Marketed Predicate Devices o K033268, "Sea-Band" wristband, by Sea-Band UK, Ltd; and K041877, Acu-Strap Motion Sickness Band, by Health Enterprises, Inc. Dev… | 2004 |
| * | K041877 | Acu-Strap Motion Sickness BandSummary page 1…o BioBands Classification Name o Acu-pressure Device Legally Marketed Predicate Devices o K033268, "Sea-Band" wristband, by Sea-Band UK, Ltd; and K041877, Acu-Strap Motion Sickness Band, by Health Enterprises, Inc. Device Description o BioBands is an adjustable wrist… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053509 | Acuband Acupressure Wrist Band Device | 2006 | 2 |
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 8 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K053509 (Acuband, Inc., 2006) has gone furthest, with 2 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?
BioBands is indicated for the relief of nausea. Nausea may be experienced due to a variety of causes, including Travel (Motion Sickness), Pregnancy (Morning Sickness), Anesthesia (Post-Operative) or Chemotherapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051397 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051397: Biobands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051397
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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