Sea-Band

GUDID 00008727001027

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.

SEA-BAND LIMITED

Acupressure wristband

• Primary Device ID: 00008727001027
• NIH Device Record Key: 0f80112b-9227-4afc-9f60-8ccdfa912795
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sea-Band
• Version Model Number: XL
• Company DUNS: 238545748
• Company Name: SEA-BAND LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00008727001027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033268

FDA Product Code

• MVV: Device, Acupressure

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-14
• Device Publish Date: 2025-08-06