FDA.reportPublic FDA data

QUELL

Primary DI
00851221006049
Brand
QUELL
Company
NeuroMetrix, Inc.
Model
QE-P02
Device description
QUELL Sport Electrode
Published
2017-03-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140586000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140586000ASCEND ELECTRODENeurometrix, Inc.2014-11-17GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851221006049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851221006049008512210060498512210060490851221006049

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-314-2781rainer_maas@neurometrix.com

Regulatory Flags#

DUNS number
957536014
Device count
1
Lot or batch
true
Expiration date on label
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
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08