510(k) · Cleared
ClearedBonine Acupressure Bands
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellspring Pharmaceutical Corporation · MVV Device, Acupressure
Cleared on Sep 1, 2021 as substantially equivalent to K193374 (Mumease, 2020) and 1 other predicate after a 79-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Sep 1, 2021
- Review
- 79 days
- Class
- Class U
- Product code
- MVV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K961050 (1997). 13 ancestors in all, the oldest K900588 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 5 generations between
- 3 generations backK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
- 2 generations backK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
- 1 generation backK193374 TumEase Acupressure BraceletsMumease · 2020
- This deviceK211823 Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021
Show all 9 generations
- Root · 9 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 8 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 7 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 6 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 5 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- 4 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
- 3 generations backK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
- 2 generations backK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
- 1 generation backK193374 TumEase Acupressure BraceletsMumease · 2020
- This deviceK211823 Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −8 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −7 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| −6 | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000 | — |
| −5 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| −4 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| −3 | K110563 | Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management… | Therapeutics 101, Inc (Dba Pressure Point, Inc.) | 2011 | — |
| −2 | K142471 | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist… | Pressure Point, Inc. | 2014 | — |
| −1 | K193374 | TumEase Acupressure Bracelets | Mumease | 2020 | — |
| 0 (this device) | K211823 | Bonine Acupressure Bands | Wellspring Pharmaceutical Corporation | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1999 | 2 | 0 |
| 2004 | 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 7.0 · 8 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K193374 | TumEase Acupressure BraceletsSummary page 4…assified – Pre-Amendment Predicate Device(s): Primary Predicate: TumEase Acupressure Bracelets K193374 510(k) Holder: MumEase Secondary Predicate:… | 2020 |
| * | K033268 | Sea-BandSummary page 4…510(k) Holder: MumEase Secondary Predicate: Sea-Band K033268 510(k) Holder: Sea-Band Ltd Device Description: Bonine Acupressure Bands are acupressure device… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K193374.
How does its category compare?
All MVV devicesMVV Device, Acupressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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?
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211823: Bonine Acupressure Bands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211823
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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