TM-400 TM-400

GUDID 04983087007932

Traction Device

ITO CO., LTD.

Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered traction system Intermittent powered 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