E-Fit

GUDID 05999887598029

Fit-Pro Kereskedelmi es Szolgaltato Korlatolt Felelossegu Tarsasag

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 05999887598029
• NIH Device Record Key: c08a40ee-4ddf-4a54-8aab-f2dbbde7c0c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-Fit
• Version Model Number: Infinity
• Company DUNS: 366811421
• Company Name: Fit-Pro Kereskedelmi es Szolgaltato Korlatolt Felelossegu Tarsasag
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999887598029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202148

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: 2
• Public Version Date: 2023-06-02
• Device Publish Date: 2022-12-16

On-Brand Devices [E-Fit]

• 05999887598012: EF-1280
• 05999887598029: Infinity