TM-400 TM-400

GUDID 04983087007932

Traction Device

ITO CO., LTD.

Intermittent traction system
Primary Device ID04983087007932
NIH Device Record Key06066111-fe0b-46a4-9e8e-1fde8e106c25
Commercial Distribution StatusIn Commercial Distribution
Brand NameTM-400
Version Model NumberTM-400
Catalog NumberTM-400
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
GS104983087007932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ITHEquipment, Traction, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by ITO CO., LTD.

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04983087008496 - ES-1602019-10-23 Electro Stimulator Therapy Unit
04983087007932 - TM-4002018-07-06Traction Device
04983087007932 - TM-4002018-07-06 Traction Device

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