510(k) · Cleared
ClearedTumEase Acupressure Bracelets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mumease · MVV Device, Acupressure
Cleared on Mar 4, 2020 as substantially equivalent to K041877 (Health Ent., Inc., 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 4, 2020
- Review
- 90 days
- Class
- Class U
- Product code
- MVV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K961050 (1997). 12 ancestors in all, the oldest K900588 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
- 7 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
- 6 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
- 5 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
- 4 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
- 3 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
- 2 generations backK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
- 1 generation backK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
- This deviceK193374 TumEase Acupressure BraceletsMumease · 2020
- Descendant · cites it directly · 0 of its ownK220289 FridaMom Anti-Nausea BandsFridababy, LLC · 2022
- Descendant · cites it directly · 0 of its ownK211823 Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K961050 | Reliefband Tens Unit (Modification) | Maven Labs, Inc. | 1997 | — |
| −7 | K980333 | Reliefband | Woodside Biomedical, Inc. | 1998 | — |
| −6 | K982436 | Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R | Woodside Biomedical, Inc. | 1998 | — |
| −5 | K994387 | Reliefband NST Device, Model WB-2L, WB-6L, WB-RL | Woodside Biomedical, Inc. | 2000 | — |
| −4 | K020180 | Reliefband Device, Models RB-DL, RB-EL, RB-RL | Woodside Biomedical, Inc. | 2002 | — |
| −3 | K033268 | Sea-Band | Sea-Band UK, Ltd. | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K193374 | TumEase Acupressure Bracelets | Mumease | 2020 | — |
| +1 | K220289 | FridaMom Anti-Nausea Bands | Fridababy, LLC | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 K220289 FridaMom Anti-Nausea Bandsscore 6.0 · 9 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 |
|---|---|---|---|
| * | K041877 | Acu-Strap Motion Sickness BandSummary page 4…Pressure Band, Acupressure Device Product Code: MVV Device Classification: Unclassified Predicate Devices: Acu-Strap (K041877) Pressure Right (K142471) Device Description: The TumEase Acupressure bracelet is a wrist brac… | 2004 |
| * | K142471 | Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist StripSummary page 4…MVV Device Classification: Unclassified Predicate Devices: Acu-Strap (K041877) Pressure Right (K142471) Device Description: The TumEase Acupressure bracelet is a wrist bracelet that has a small round bump on the inside face of the… | 2014 |
What descends from it? (2)
2 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 23 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K220289 (Fridababy, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K041877.
How does its category compare?
All MVV devicesMVV Device, Acupressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
The acupressure bracelets 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/K193374 · printed Nov 4, 2026
Cite this page
510(k) Report. “K193374: TumEase Acupressure Bracelets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K193374
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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