D function

GUDID 04983087012394

Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief

ITO CO., LTD.

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• Primary Device ID: 04983087012394
• NIH Device Record Key: e21233af-a22a-4200-8bb9-0cec8844d380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D function
• Version Model Number: D function
• 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	04983087012394 [Primary]
GS1	24983087012398 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203525

FDA Product Code

• NUW: Stimulator, Muscle, Powered, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-17
• Device Publish Date: 2021-09-09

Devices Manufactured by ITO CO., LTD.

• 04983087012394 - D function: 2021-09-17Dual Channel Electrical Muscle Stimulator for TMJ Pain Relief
• 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: 2018-07-06 Traction Device