D function

Primary DI
04983087012394
Brand
D function
Company
ITO CO., LTD.
Model
D function
Device description
Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
Published
2021-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NUWStimulator, Muscle, Powered, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUWStimulator, Muscle, Powered, DentalPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203525000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203525000D functionIto Co., Ltd.2021-05-05NUW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24983087012398PackageGS110In Commercial Distribution
04983087012394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2498308701239824983087012398
04983087012394049830870123944983087012394

GMDN Terms#

Term, Definition table
TermDefinition
Jaw muscle electrical stimulation systemAn assembly of devices designed to apply electrical stimuli to the mastication and facial muscles. It typically consists of an electrical pulse generator, appropriate active electrodes that are usually placed on the coronoid notches of the mandible, and a common return electrode located at the nape of the neck below the hairline. The device is typically used in dentistry to relax the facial and mastication muscles to treat temperomandibular joint (TMJ) dysfunction and associated pain, to relieve symptoms associated with muscle spasm, to take occlusal registrations and denture impressions, and for other therapeutic measures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690637194
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04983087007932TM-400TM-400TM-4002016-09-24
04983087008403ES-130ES-130ES-1302016-09-24
04983087008496ES-160ES-160ES-1602016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D79240602Myotrode One With GelMYOTRONICS NOROMED, INCNUW2016-09-19
D79240702Myotrode One without GelMYOTRONICS NOROMED, INCNUW2016-09-19
D79243003Myotrode SG Solid Gel TENS ElectrodesMYOTRONICS NOROMED, INCNUW2016-09-19
D79244500J5 Myo-MonitorMYOTRONICS NOROMED, INCNUW2016-08-18
D79245000BNS-40 Home Treatment UnitMYOTRONICS NOROMED, INCNUW2016-08-18