# MVV: Device, Acupressure

- Device class: U; regulation: 21 CFR —
- FDA decisions: 13
- 510(k) review time 2021–2025: median 114 days (middle half 96–131)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2004: 3
- 2005: 1
- 2006: 1
- 2007: 1
- 2011: 1
- 2012: 1
- 2014: 1
- 2020: 1
- 2021: 1
- 2022: 1

## Most-cited predicates
- K033268: Sea-Band (2004), cited by 7
- K041877: Acu-Strap Motion Sickness Band (2004), cited by 4
- K193374: TumEase Acupressure Bracelets (2020), cited by 2
- K041766: Ezy-Travel Wristband (2004), cited by 1
- K053509: Acuband Acupressure Wrist Band Device (2006), cited by 1
- K070766: Psi Bands (2007), cited by 1
- K900588: Acu-Band Accupressure Wrist Band (1990), cited by 1
- K142471: Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip (2014), cited by 1
- K110563: Pressure Right, Single-Use, Disposable, Pressure-Sensitive Emetic-Management Wrist Strip (2011), cited by 1
- K051397: Biobands (2005), cited by 1

Source page: https://510kreport.com/product-code/MVV
Data by year (CSV): https://510kreport.com/product-code/MVV.csv