Etekcity TENS Unit

GUDID 00817915020012

ETEKCITY CORPORATION

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00817915020012
• NIH Device Record Key: 0872ae02-dd3c-4fd6-8b96-baf5e6a2a012
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Etekcity TENS Unit
• Version Model Number: ETU-134
• Company DUNS: 079578783
• Company Name: ETEKCITY CORPORATION
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817915020012 [Primary]
GS1	10817915020019 [Package]; Package: Master Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130802

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2019-04-22

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