510(k) Report

510(k) · Cleared

Cleared

Acuband Acupressure Wrist Band Device

K053509510(k) TraditionalCleared Aug 16, 2006243-day reviewClass U

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

Acuband, Inc. · MVV Device, Acupressure

Cleared on Aug 16, 2006 as substantially equivalent to K051397 (Biobands Distributors, Inc., 2005) and 3 other predicates after a 243-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it.

Decided
Aug 16, 2006
Review
243 days
Class
Class U
Product code
MVV
Recalls
None
Predicates
4

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, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1999: 2 other ancestors1990: 1 other ancestor2007: 1 descendant cleared2012: 1 descendant clearedK961050 · Reliefband Tens Unit (Modification) · Maven Labs, Inc. · 1997K980333 · Reliefband · Woodside Biomedical, Inc. · 1998K982436 · Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R · Woodside Biomedical, Inc. · 1998K994387 · Reliefband NST Device, Model WB-2L, WB-6L, WB-RL · Woodside Biomedical, Inc. · 2000K020180 · Reliefband Device, Models RB-DL, RB-EL, RB-RL · Woodside Biomedical, Inc. · 2002K033268 · Sea-Band · Sea-Band UK, Ltd. · 2004K041877 · Acu-Strap Motion Sickness Band · Health Ent., Inc. · 2004K051397 · Biobands · Biobands Distributors, Inc. · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K051397 · Biobands · Biobands Distributors, Inc. · 2005K041877 · Acu-Strap Motion Sickness Band · Health Ent., Inc. · 2004K033268 · Sea-Band · Sea-Band UK, Ltd. · 2004K020180 · Reliefband Device, Models RB-DL, RB-EL, RB-RL · Woodside Biomedical, Inc. · 2002K994387 · Reliefband NST Device, Model WB-2L, WB-6L, WB-RL · Woodside Biomedical, Inc. · 2000K982436 · Reliefband NST Device, Model #'S WB-2, WB-6 and WB-R · Woodside Biomedical, Inc. · 1998K980333 · Reliefband · Woodside Biomedical, Inc. · 1998K961050 · Reliefband Tens Unit (Modification) · Maven Labs, Inc. · 1997−50
  1. Root · 8 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
  2. 7 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
  3. 6 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
  4. 5 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
  5. 4 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
  6. 3 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
  7. 2 generations backK041877 Acu-Strap Motion Sickness BandHealth Ent., Inc. · 2004
  8. 1 generation backK051397 BiobandsBiobands Distributors, Inc. · 2005
  9. This deviceK053509 Acuband Acupressure Wrist Band DeviceAcuband, Inc. · 2006
  10. Descendant · cites it directly · 1 of its ownK070766 Psi BandsPsi Health Solutions, Inc. · 2007 · Recalled
  11. Descendant · 2 generations on · 0 of its ownK110821 Barf BandDoodlebug Products, LLC · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K070766Psi BandsPsi Health Solutions, Inc. · 2007 · cites it directly1descendant
  • K110821Barf BandDoodlebug Products, LLC · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K961050Reliefband Tens Unit (Modification)Maven Labs, Inc.1997—
−7K980333ReliefbandWoodside Biomedical, Inc.1998—
−6K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc.1998—
−5K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc.2000—
−4K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc.2002—
−3K033268Sea-BandSea-Band UK, Ltd.2004—
−2K041877Acu-Strap Motion Sickness BandHealth Ent., Inc.2004—
−1K051397BiobandsBiobands Distributors, Inc.2005—
0 (this device)K053509Acuband Acupressure Wrist Band DeviceAcuband, Inc.2006—
+1K070766Psi BandsPsi Health Solutions, Inc.20071
+2K110821Barf BandDoodlebug Products, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199920
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201210
FIG. 1 — Lineage of K053509, 1997–2012Source: 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 7.0 · 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? (4)

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
*K051397Biobands
Summary page 1
…Device Identification: >Device name: Acuband >Classification name: Acupressure wrist band FDA Approved Predicate Devices: > BioBands (K051397) >Acu-Strap (K041877) > Sea-Band (K033268) > Ezy-Travel Band (K041766) Device Description: >The Acubands consist of a pair of…
Biobands Distributors, Inc.2005—
*K041877Acu-Strap Motion Sickness Band
Summary page 1
…: >Device name: Acuband >Classification name: Acupressure wrist band FDA Approved Predicate Devices: > BioBands (K051397) >Acu-Strap (K041877) > Sea-Band (K033268) > Ezy-Travel Band (K041766) Device Description: >The Acubands consist of a pair of wrist bands with a ha…
Health Ent., Inc.2004—
*K033268Sea-Band
Summary page 1
…Acuband >Classification name: Acupressure wrist band FDA Approved Predicate Devices: > BioBands (K051397) >Acu-Strap (K041877) > Sea-Band (K033268) > Ezy-Travel Band (K041766) Device Description: >The Acubands consist of a pair of wrist bands with a half-round button affixe…
Sea-Band UK, Ltd.2004—
*K041766Ezy-Travel Wristband
Summary page 1
…sification name: Acupressure wrist band FDA Approved Predicate Devices: > BioBands (K051397) >Acu-Strap (K041877) > Sea-Band (K033268) > Ezy-Travel Band (K041766) Device Description: >The Acubands consist of a pair of wrist bands with a half-round button affixed to the interior…
Apothecary Products, Inc.2004—

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K070766Psi BandsPsi Health Solutions, Inc.20071

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 9 years and passes through 6 companies; a new generation was cleared every 11 months on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K070766 (Psi Health Solutions, Inc., 2007) has gone furthest, with 1 descendant 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.

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?

Acubands are indicated for the relief of nausea. Nausea is a symptom which can be experienced by causes such as motion sickness, morning sickness (pregnancy), chemotherapy and post operative from anesthesia.

Indications for use as stated in the FDA summary.

Recent decisions in MVV

The MVV category page

  • K220289FridaMom Anti-Nausea BandsFridababy, LLC · 2022
  • K211823Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021
  • K193374TumEase Acupressure BraceletsMumease · 2020
  • K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist StripPressure Point, Inc. · 2014
  • K110821Barf BandDoodlebug Products, LLC · 2012

https://510kreport.com/device/K053509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053509: Acuband Acupressure Wrist Band Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053509

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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