FDA.reportPublic FDA data

QUELL FIBROMYALGIA

Primary DI
00851221006643
Brand
QUELL FIBROMYALGIA
Company
NeuroMetrix, Inc.
Model
QE-FMG
Device description
Prescription Starter Kit for Government Markets (includes 1 Device, 2 Packs of Quell Electrodes with UDI 00851221006018, 1 Charger, 1 Charger Cable, 1 Sport Band)
Published
2023-11-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia SymptomsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210046000Quell-FMNeurometrix, Inc.2022-05-18QSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851221006643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851221006643008512210066438512210066430851221006643

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
17813142706Mike_Dulude@neurometrix.com

Regulatory Flags#

DUNS number
957536014
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851221006087NC-stat DPNCheckNC-DP2DB-025, DB-0502016-12-01
00851221006100ADVANCENC-S322016-09-07
00851221006117ADVANCENC-S332016-09-07
00851221006124ADVANCENC-S342016-09-07
00851221006131ADVANCENC-S412016-09-07
00851221006148ADVANCENC-S422016-09-07
00851221006162ADVANCENC-S722016-09-07
00851221006193ADVANCENC-S812016-09-08
00851221006209ADVANCENC-S822016-09-08
00851221006216ADVANCENC-S912016-09-08
00851221006223ADVANCENC-S922016-09-08
00851221006230ADVANCENC-S932016-09-08
00851221006247ADVANCENC-S942016-09-08
00851221006056DPNCheck 2.0NC-0402022-12-20
00851221006575DPNCheck, ChinaNC-030-C2022-12-20
00851221006582DPNCheck, JapanNC-030-JFD2022-12-20
00851221006094ADVANCENC-S312016-09-07
00851221006155ADVANCENC-S712016-09-07
00851221006179ADVANCENC-S732016-09-07
00851221006186ADVANCENC-S742016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851221006780Quell Charger CableNeuroMetrix, Inc.QSQ2026-01-09
00851221006797Quell Charger AdapterNeuroMetrix, Inc.QSQ2026-01-09
00851221006513Quell FibromyalgiaNeuroMetrix, Inc.QSQ2025-08-01
00851221006704QuellNeuroMetrix, Inc.QSQ2025-08-01
00851221006735Quell 2.0NeuroMetrix, Inc.QSQ2025-08-01
00851221006742Quell 2.0NeuroMetrix, Inc.QSQ2025-08-01
00851221006766Quell 1.0NeuroMetrix, Inc.QSQ2025-08-01
00851221006810Quell FibromyalgiaNeuroMetrix, Inc.QSQ2025-08-01
00851221006407QUELL FIBROMYALGIANeuroMetrix, Inc.QSQ2024-08-08
00851221006384QUELL FIBROMYALGIANeuroMetrix, Inc.QSQ2024-07-17
00851221006650QUELL FIBROMYALGIANeuroMetrix, Inc.QSQ2023-11-21
00851221006612QUELL FIBROMYALGIANeuroMetrix, Inc.QSQ2022-12-20