Identity
- Trade Name
- Reliefband® 50 Hours FDA UDI
- Generic Name
- Anti-nausea transcutaneous electrical nerve stimulation wristband FDA UDI
- Device Name
- Reliefband® 50 Hours is a therapeutic device incorporated into a wristband which has stimulating electrodes that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Reliefband 50 Hours offers fifty hours of treatment time. The batteries of Reliefband® 50 Hours are non-replaceable. Reliefband® 50 Hours is a wearable device indicated for use in the treatment of nausea and vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy, as well as an adjunct to antiemetics in reducing post-operative nausea. FDA UDI
- Model / Reference
- RB50 FDA UDI
- Description
- Reliefband® 50 Hours is a therapeutic device incorporated into a wristband which has stimulating electrodes that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Reliefband 50 Hours offers fifty hours of treatment time. The batteries of Reliefband® 50 Hours are non-replaceable. Reliefband® 50 Hours is a wearable device indicated for use in the treatment of nausea and vomiting associated with physician-diagnosed migraine, hangover, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy, as well as an adjunct to antiemetics in reducing post-operative nausea. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00661168000167 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® 50 Hours 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 8aab1f77-154b-427f-8825-fff42eafb9c1 36 fields · synced Jun 8, 2026