FDA UDI
In Commercial Distribution
🇺🇸 United States
Sea-Band
DI: 00008727001027
·
Model: XL
·
SEA-BAND LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sea-Band
- Primary DI
- 00008727001027
- Version / Model
- XL
- Company Name
- SEA-BAND LIMITED
- Labeler DUNS
- 238545748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-06
- Public Version
- 1
- Public Version Date
- 2025-08-14
- Public Version Status
- New
- Public Device Record Key
- 0f80112b-9227-4afc-9f60-8ccdfa912795
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MVV | Device, Acupressure | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58072 | Acupressure wristband | A device designed to be worn on the wrist(s) for the application of pressure to the Nei-kuan (P6) acupressure point, the area identified to help relieve the sensation of nausea. The device is typically an adjustable strap made of medical grade thermoplastic material that includes a mechanical pressure dial (a notched wheel) that can be manually rotated by the user to increase or decrease the applied acupressure. It is intended to alleviate nausea caused by various conditions including pregnancy (morning sickness), motion sickness (travel sickness), post anaesthesia sickness, and chemotherapy sickness. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00008727001027 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K033268 | 000 |