QUELL FIBROMYALGIA

Basic Information

• Brand Name: QUELL FIBROMYALGIA
• Primary DI: 00851221006629
• Version / Model: QE-HWB-P01
• Company Name: NEUROMETRIX, INC.
• Labeler DUNS: 957536014
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-06
• Public Version: 1
• Public Version Date: 2023-03-14
• Public Version Status: New
• Public Device Record Key: fb6349aa-584c-44cc-8ba4-cd498819a783

Device Description

Quell Healthwarehouse Bundle - 3 Standard Electrode packs and 1 Standard Quell Band (3 pack electrodes with UDI 00851221006018 and 1 Quell Band with UDI 00851221006513 in poly bag)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXY	Electrode, Cutaneous	Neurology	882.1320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11425	Electrode conductive medium	A non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851221006629	GS1

Premarket Submissions

Submission Number	Supplement Number
K140586	000