FDA UDI
In Commercial Distribution
🇺🇸 United States
Reliefband® Classic
DI: 00661168600015
·
Model: 1.5
·
RELIEFBAND TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Reliefband® Classic
- Primary DI
- 00661168600015
- Version / Model
- 1.5
- Catalog Number
- 1.5
- Company Name
- RELIEFBAND TECHNOLOGIES LLC
- Labeler DUNS
- 080294073
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-29
- Public Version
- 1
- Public Version Date
- 2021-07-07
- Public Version Status
- New
- Public Device Record Key
- 1b840467-95f2-44b7-946c-b78084b9611d
Device Description
Reliefband® Classic is a digital therapeutic device incorporated into a wristband which has a stimulating electrode that is worn on the underside of the wrist. It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. Batteries will last approximately 150 hours of active use at power level 3 or below. The batteries of Reliefband® are user replaceable. Replace batteries in unit when they become drained.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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 | 20661168600019 | GS1 | Inner | 12 | In Commercial Distribution | |
| Primary | 00661168600015 | GS1 | ||||
| Package | 10661168600012 | GS1 | Master | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 27 Degrees Celsius