Identity
- Trade Name
- Sea-Band FDA UDI
- Generic Name
- Acupressure wristband FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- XL FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00008727001027 FDA UDI
- 510(k) Number
- K033268 FDA UDI
- FDA Product Code
- MVV FDA UDI
- GMDN Term
- Acupressure wristband FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Acupressure wristband
Sea-Band by Sea-Band Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K033268 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Sea-Band Limited
Sources (1)
- FDA UDI 0f80112b-9227-4afc-9f60-8ccdfa912795 34 fields · synced May 30, 2026