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Quell Fibromyalgia

FDA UDI

Class II (US FDA UDI)

by Neurometrix, Inc.

Identity

Trade Name
QUELL FIBROMYALGIA FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
Prescription Starter Kit (includes device, 1 pack of electrode with IDU 00851221006018, 1 charger, 1 charger cable, 1 sport band) FDA UDI
Model / Reference
QE-FMS FDA UDI
Description
Prescription Starter Kit (includes device, 1 pack of electrode with IDU 00851221006018, 1 charger, 1 charger cable, 1 sport band) FDA UDI

Identifiers

Primary DI / UDI-DI
00851221006612 FDA UDI
FDA Product Code
QSQ FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5888 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Quell Fibromyalgia by Neurometrix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurometrix, Inc.

Sources (1)

  • FDA UDI 773f36d5-ad01-49ff-80f9-7c67ea7bbe41 35 fields · synced May 30, 2026