TM-400 TM-400

GUDID 04983087007932

Traction Device

ITO CO., LTD.

Intermittent traction system

• Primary Device ID: 04983087007932
• NIH Device Record Key: 06066111-fe0b-46a4-9e8e-1fde8e106c25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TM-400
• Version Model Number: TM-400
• Catalog Number: TM-400
• Company DUNS: 690637194
• Company Name: ITO CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04983087007932 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081247

FDA Product Code

• ITH: Equipment, Traction, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by ITO CO., LTD.

• 04983087012394 - D function: 2021-09-17 Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
• 04983087008403 - ES-130: 2019-10-23 Electro Acupuncture Therapy Unit
• 04983087008496 - ES-160: 2019-10-23 Electro Stimulator Therapy Unit
• 04983087007932 - TM-400: 2018-07-06Traction Device
• 04983087007932 - TM-400: 2018-07-06 Traction Device