Identity
- Trade Name
- Reliefband® Premier Plus FDA UDI
- Generic Name
- Anti-nausea transcutaneous electrical nerve stimulation wristband FDA UDI
- Device Name
- Reliefband® Premier Plus is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. Reliefband Premier Plus is your everyday wearable, providing an advanced nausea relief solution, unparalleled convenience, and efficiency with a digital display, clock, and Smart Skin-Sensing technology to preserve battery life. A fully charged battery will last for approximately 18 -25 hours of continuous use at the mid-power level or below. FDA UDI
- Model / Reference
- RBPLUS FDA UDI
- Description
- Reliefband® Premier Plus is a rechargeable, digital wearable device that is worn on the wrist. It consists of a hypoallergenic band with a control panel on top and two electrical contacts underneath. The two contacts must be placed firmly against the underside of your wrist at the P6 location. Reliefband Premier Plus is your everyday wearable, providing an advanced nausea relief solution, unparalleled convenience, and efficiency with a digital display, clock, and Smart Skin-Sensing technology to preserve battery life. A fully charged battery will last for approximately 18 -25 hours of continuous use at the mid-power level or below. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00661168000181 FDA UDI
- 510(k) Number
- K191547 FDA UDI
- FDA Product Code
- GZJ FDA UDI
- GMDN Term
- Anti-nausea transcutaneous electrical nerve stimulation wristband FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5890 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anti-nausea transcutaneous electrical nerve stimulation wristband
Reliefband® Premier Plus by ReliefBand Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 II | Pending data |
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Manufacturer
- Manufacturer
- ReliefBand Technologies
Sources (1)
- FDA UDI b6c918dc-c3ac-4c0c-b46e-9a5ab4e81d2a 36 fields · synced Jun 1, 2026