Fit Relief

GUDID 00850018806800

Fit Relief Device

Heatinaclick LLC

Psychiatric-therapy/physical-therapy transcutaneous electrical stimulation system

• Primary Device ID: 00850018806800
• NIH Device Record Key: 7af9837e-cc52-47d4-869a-ac5553196613
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fit Relief
• Version Model Number: 6404
• Company DUNS: 043038693
• Company Name: Heatinaclick LLC
• 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: true
• Serial Number: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850018806800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191938

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-10
• Device Publish Date: 2025-01-31

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