FDA UDI
In Commercial Distribution
🇺🇸 United States
Reliefband® Premier Plus
DI: 00661168000181
·
Model: RBPLUS
·
RELIEFBAND TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Reliefband® Premier Plus
- Primary DI
- 00661168000181
- Version / Model
- RBPLUS
- Company Name
- RELIEFBAND TECHNOLOGIES LLC
- Labeler DUNS
- 080294073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-24
- Public Version
- 1
- Public Version Date
- 2025-03-04
- Public Version Status
- New
- Public Device Record Key
- b6c918dc-c3ac-4c0c-b46e-9a5ab4e81d2a
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63388 | Anti-nausea transcutaneous electrical nerve stimulation wristband | An electrically-powered device designed to be worn on the wrist of a patient to apply electrical stimuli to the median nerve through the skin (transcutaneously), to help relieve the sensation of nausea caused by various conditions [e.g., pregnancy (morning sickness), motion (travel sickness), chemotherapy]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10661168000188 | GS1 | Inner | 6 | In Commercial Distribution | |
| Primary | 00661168000181 | GS1 | ||||
| Package | 20661168000185 | GS1 | Master | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191547 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 38 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 27 Degrees Celsius