AccessGUDID - DEVICE: Reliefband® Sport

GUDID

Device Identifier (DI) Information

Brand Name: Reliefband® Sport - Black
Version or Model: RBSPT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RELIEFBAND TECHNOLOGIES LLC

Primary DI Number: 00661168000037
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080294073 *Terms of Use

Device Description: Reliefband® Sport is a rechargeable, digital therapeutic device that has stimulating electrodes and is worn on the underside of the wrist by attaching to a wristband (included). It provides relief from nausea and vomiting through gentle electrical stimulation of the median nerve. A fully charged battery will last for approximately 25 hours of continuous use at the mid-power level or below. Reliefband® Sport is indicated for use in the treatment of nausea and vomiting associated with physician-diagnosed migraines, hangovers, anxiety, motion sickness, chemotherapy and morning sickness from pregnancy. Reliefband® Sport is also indicated as an adjunct to antiemetics in reducing postoperative nausea. For over the counter use.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191547	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 0 and 38 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc6d72dd-ecb2-4203-aa34-9090224a93b1
Public Version Date: March 04, 2025
Public Version Number: 1
DI Record Publish Date: February 24, 2025