D function

GUDID 04983087012394

Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief

ITO CO., LTD.

Jaw muscle electrical stimulation system
Primary Device ID04983087012394
NIH Device Record Keye21233af-a22a-4200-8bb9-0cec8844d380
Commercial Distribution StatusIn Commercial Distribution
Brand NameD function
Version Model NumberD function
Company DUNS690637194
Company NameITO CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104983087012394 [Primary]
GS124983087012398 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NUWStimulator, Muscle, Powered, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-17
Device Publish Date2021-09-09

Devices Manufactured by ITO CO., LTD.

04983087012394 - D function2021-09-17Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
04983087012394 - D function2021-09-17 Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
04983087008403 - ES-1302019-10-23 Electro Acupuncture Therapy Unit
04983087008496 - ES-1602019-10-23 Electro Stimulator Therapy Unit
04983087007932 - TM-4002018-07-06 Traction Device

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