NuFACE

Primary DI
00810075940183
Brand
NuFACE
Company
Nuface
Model
42077
Device description
Trinity Kit WHITE W/ELE
Published
2021-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131251000
K181008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131251000TRINITY ELECarol Cole Company2013-10-01NFO
K181008000NuFACE TrinityCarol Cole Company Dba Nuface2018-10-11NFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075940183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075940183008100759401838100759401830810075940183

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023980008
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810075943276NuFACE421942026-01-27
00810075944570NuFACE422512026-01-27
00810075944952NuFACE422602025-08-28
00810075941418NuFACE421162023-06-08
00810075941449NuFACE420192023-06-08
00850019720228NuFACE420002023-06-08
00850019720235NuFACE420012023-06-08
00850019720280NuFACE420062023-06-08
00850019720303NuFACE420082023-06-08
00850019720556NuFACE420102023-06-08
00850019720563NuFACE420112023-06-08
00850019720655NuFACE420162023-06-08
00850019720662NuFACE420152023-06-08
00850019720679NuFACE420202023-06-08
00810075940121NuFACE420712021-03-19
00810075940145NuFACE420732021-03-19
00810075940176NuFACE420742021-03-19
00810075940206NuFACE420792021-03-19
00810075940213NuFACE420822021-03-19
00810075940237NuFACE420802021-03-19