Reliefband® Flex

Basic Information

• Brand Name: Reliefband® Flex
• Primary DI: 00661168000174
• Version / Model: RBFLX
• 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: b3819c50-95df-4f45-a633-55059d46b60b

Device Description

Reliefband® Flex 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 350+ hours of active use at power level 3 or below. The batteries of Reliefband® Flex 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: 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
Primary	00661168000174	GS1
Package	10661168000171	GS1	Inner	12	In Commercial Distribution
Package	20661168000178	GS1	Master	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [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