Sea-Band

SEA-BAND LIMITED · Model XL · UDI-DI 00008727001027

510(k) clearances

Adverse events

Recalls

Facilities

Description

The XL Sea-Band is an elasticated band that can comfortably worn around the wrists with a circumference over 8 inches. There is a plastic button-shaped stud inserted through the band. Sea-Bands are designed to be worn around each wrist where the stud exerts pressure to the Nei-Kuan acupressure point. The Sea-Band is a simple device used to control nausea and motion sickness without the use of drugs. The device is non-powered and operates by exerting pressure on acupressure points, as such it is non-invasive and non-sterile.

Recalls

Date	Firm	Reason
2007-04-26	Psi Health Solutions	Product was marketed before its 510(k) application cleared.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.