# K211823: Bonine Acupressure Bands

- Pathway: 510(k) (Traditional)
- Applicant: Wellspring Pharmaceutical Corporation
- Decided: Sep 1, 2021 after 79 days
- Product code: MVV (Device, Acupressure)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K961050 (1997). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193374: TumEase Acupressure Bracelets, Mumease (2020) Summary page 4.
- K033268: Sea-Band, Sea-Band UK, Ltd. (2004) Summary page 4.

## Indications for use
Bonine Acupressure Bands are intended to reduce symptoms of nausea. Nausea may be experienced due to Travel/Motion, Pregnancy/Morning Sickness, Chemotherapy, and Anesthesia (post-procedure).

Source page: https://510kreport.com/device/K211823
Methodology: https://510kreport.com/methodology