510(k) Report

510(k) · Cleared

Cleared

Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip

K142471510(k) TraditionalCleared Dec 1, 201489-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pressure Point, Inc. · MVV Device, Acupressure

Cleared on Dec 1, 2014 as substantially equivalent to K110563 (Therapeutics 101, Inc (Dba Pressure Point, Inc.), 2011) and 1 other predicate after an 89-day review. Its family tree reaches back 7 generations to 1997. 3 later devices descend from it.

Decided
Dec 1, 2014
Review
89 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.

  1. Root · 7 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
  2. 6 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
  3. 5 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
  4. 4 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
  5. 3 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
  6. 2 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
  7. 1 generation backK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
  8. This deviceK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
  9. Descendant · cites it directly · 2 of its ownK193374 TumEase Acupressure BraceletsMumease · 2020
  10. Descendant · 2 generations on · 0 of its ownK220289 FridaMom Anti-Nausea BandsFridababy, LLC · 2022
  11. Descendant · 2 generations on · 0 of its ownK211823 Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021

Most influential descendants

Showing 3 of 3 · See all
  • K193374TumEase Acupressure BraceletsMumease · 2020 · cites it directly2descendants
  • K220289FridaMom Anti-Nausea BandsFridababy, LLC · 2022 · 2 generations on0descendants
  • K211823Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K961050Reliefband Tens Unit (Modification)Maven Labs, Inc.1997—
−6K980333ReliefbandWoodside Biomedical, Inc.1998—
−5K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc.1998—
−4K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc.2000—
−3K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc.2002—
−2K033268Sea-BandSea-Band UK, Ltd.2004—
−1K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management…Therapeutics 101, Inc (Dba Pressure Point, Inc.)2011—
0 (this device)K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist…Pressure Point, Inc.2014—
+1K193374TumEase Acupressure BraceletsMumease2020—
+2K220289FridaMom Anti-Nausea BandsFridababy, LLC2022—
+2K211823Bonine Acupressure BandsWellspring Pharmaceutical Corporation2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199920

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202110
202210
FIG. 1 — Lineage of K142471, 1997–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K193374 TumEase Acupressure Braceletsscore 7.1 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip
Summary page 4
…y Marketed Predicate Device(s) Pressure Right®, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip Manufactured by Pressure Point, Inc. 510(k) K110563 Sea-Band® Manufactured by Sea-Band UK LTD. 510(k) K033268 Page 5-1 === P…
Therapeutics 101, Inc (Dba Pressure Point, Inc.)2011—
*K033268Sea-Band
Summary page 4
…osable, Acupressure, Pressure-Sensitive Wrist Strip Manufactured by Pressure Point, Inc. 510(k) K110563 Sea-Band® Manufactured by Sea-Band UK LTD. 510(k) K033268 Page 5-1 6. Device Description The Pressure Right device is a…
Sea-Band UK, Ltd.2004—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K193374TumEase Acupressure BraceletsMumease20202

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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K193374 (Mumease, 2020) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MVV devices

MVV Device, Acupressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MVV

1in 2022

2007: 12011: 12012: 12014: 12020: 12021: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

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

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MVV

1in 2024

2010: 12022: 22023: 12024: 1
2007high 2 (2022) · low 0 (2007)2025

MAUDE reports naming product code MVV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—10
20080—00
20090—00
20100—01
20111—00
20121—00
20130—00
20141—00
20150—00
20160—00
20170—00
20180—00
20190—00
20201—00
20211—00
20221—02
20230—01
20240—01
20250—00
20260—0—

What is it indicated for?

Pressure Right® is a drug-free, Single-Use, Pressure-Sensitive Acupressure Wrist Strip, externally applied, which is indicated for relief of nausea symptoms associated with chemotherapy, post-operative, pregnancy (morning sickness) and travel/motion.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K142471: Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142471

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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