FDA.reportPublic FDA data

QUELL 2.0

Primary DI
00851221006483
Brand
QUELL 2.0
Company
NeuroMetrix, Inc.
Model
QE-NAZ
Device description
Quell 2.0 Starter Kit for Amazon (Includes: Device, 1 Standard Band, 1 Sleeve of Sport Electrode (2electrodes), Charging Components (cable and brick)
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851221006483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851221006483008512210064838512210064830851221006483

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
781-314-2781rainer_maas@neurometrix.com
973-435-8314quellsupport@electrocore.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

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
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00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
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00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11