Therabody

GUDID 00840295408224

TheraFace Conductive Gel Intended to be used with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.

Therabody, Inc.

Electrode conductive medium

• Primary Device ID: 00840295408224
• NIH Device Record Key: dc9cfdee-9da9-44cd-889c-7098899b5190
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Therabody
• Version Model Number: TheraFace Conductive Gel
• Company DUNS: 080550811
• Company Name: Therabody, Inc.
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840295408224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022494

FDA Product Code

• GYB: Media, Electroconductive

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: 2025-02-03
• Device Publish Date: 2025-01-26

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