ES-130 ES-130

GUDID 04983087008403

Electro Acupuncture Therapy Unit

ITO CO., LTD.

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• Primary Device ID: 04983087008403
• NIH Device Record Key: b5922f5f-39ea-46d8-b3f2-4463222425ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ES-130
• Version Model Number: ES-130
• Catalog Number: ES-130
• 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	04983087008403 [Primary]
GS1	14983087008400 [Package]; Package: [20 Units]; In Commercial Distribution
GS1	24983087008407 [Package]; Contains: 14983087008400; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081943

FDA Product Code

• BWK: Stimulator, Electro-Acupuncture

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• 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: 2019-10-23Electro Acupuncture Therapy Unit
• 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