510(k) Report

510(k) · Cleared

Cleared

FridaMom Anti-Nausea Bands

K220289510(k) TraditionalCleared Jun 29, 2022148-day reviewClass U

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

Fridababy, LLC · MVV Device, Acupressure

Cleared on Jun 29, 2022 as substantially equivalent to K193374 (Mumease, 2020) and 1 other predicate after a 148-day review. Its family tree reaches back 9 generations to 1997.

Decided
Jun 29, 2022
Review
148 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.

Other ancestors, by year cleared 2004: 1 other ancestor1999: 2 other ancestors1990: 1 other ancestorK961050 · 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. · 2004K110563 · Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip · Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011K142471 · Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip · Pressure Point, Inc. · 2014K193374 · TumEase Acupressure Bracelets · Mumease · 20201990199520002005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor3 generations back: 3 other ancestors K193374 · TumEase Acupressure Bracelets · Mumease · 2020K142471 · Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip · Pressure Point, Inc. · 2014K110563 · Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip · Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011K033268 · 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 · 9 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
  2. 5 generations between
  3. 3 generations backK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
  4. 2 generations backK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
  5. 1 generation backK193374 TumEase Acupressure BraceletsMumease · 2020
  6. This deviceK220289 FridaMom Anti-Nausea BandsFridababy, LLC · 2022
Show all 9 generations
  1. Root · 9 generations backK961050 Reliefband Tens Unit (Modification)Maven Labs, Inc. · 1997
  2. 8 generations backK980333 ReliefbandWoodside Biomedical, Inc. · 1998
  3. 7 generations backK982436 Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc. · 1998
  4. 6 generations backK994387 Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc. · 2000
  5. 5 generations backK020180 Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc. · 2002
  6. 4 generations backK033268 Sea-BandSea-Band UK, Ltd. · 2004
  7. 3 generations backK110563 Pressure Right, Single-Use, Disposable, Pressure-Sensitive…Therapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011
  8. 2 generations backK142471 Pressure Right, Single-Use, Disposable, Acupressure…Pressure Point, Inc. · 2014
  9. 1 generation backK193374 TumEase Acupressure BraceletsMumease · 2020
  10. This deviceK220289 FridaMom Anti-Nausea BandsFridababy, LLC · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K961050Reliefband Tens Unit (Modification)Maven Labs, Inc.1997—
−8K980333ReliefbandWoodside Biomedical, Inc.1998—
−7K982436Reliefband NST Device, Model #'S WB-2, WB-6 and WB-RWoodside Biomedical, Inc.1998—
−6K994387Reliefband NST Device, Model WB-2L, WB-6L, WB-RLWoodside Biomedical, Inc.2000—
−5K020180Reliefband Device, Models RB-DL, RB-EL, RB-RLWoodside Biomedical, Inc.2002—
−4K033268Sea-BandSea-Band UK, Ltd.2004—
−3K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management…Therapeutics 101, Inc (Dba Pressure Point, Inc.)2011—
−2K142471Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist…Pressure Point, Inc.2014—
−1K193374TumEase Acupressure BraceletsMumease2020—
0 (this device)K220289FridaMom Anti-Nausea BandsFridababy, LLC2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199920
200410
FIG. 1 — Lineage of K220289, 1997–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
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
*K193374TumEase Acupressure Bracelets
Summary page 4
…ice Classification: Class: Unclassified (Pre-Amendment) Product Code: MVV Equivalent Device: TumEase Acupressure Bracelets (K193374, primary predicate) Acu-strap Travel and Motion Sickness Band (K041877, secondary…
Mumease2020—
*K041877Acu-Strap Motion Sickness Band
Summary page 4
…uct Code: MVV Equivalent Device: TumEase Acupressure Bracelets (K193374, primary predicate) Acu-strap Travel and Motion Sickness Band (K041877, secondary predicate) Device Description: The FridaMom Anti-nausea Bands are adjustable wrist b…
Health Ent., Inc.2004—

Also cleared against K193374: 1 other device →

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 25 years and passes through 7 companies; a new generation was cleared every 2.0 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 devices

MVV Device, Acupressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?

The FridaMom Anti-Nausea Bands are intended to reduce symptoms of nausea which may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

Indications for use as stated in the FDA summary.

Also cleared against K193374

1 other device cites the same predicate.

  • K211823Bonine Acupressure BandsWellspring Pharmaceutical Corporation · 2021

Recent decisions in MVV

The MVV category page

  • 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
  • K110563Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist StripTherapeutics 101, Inc (Dba Pressure Point, Inc.) · 2011

https://510kreport.com/device/K220289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K220289: FridaMom Anti-Nausea Bands.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220289

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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