Perifit

GUDID 03770014642448

Kegel Exerciser with App

X6 INNOVATIONS

Pelvic floor muscle exerciser

• Primary Device ID: 03770014642448
• NIH Device Record Key: 8728cd81-aeac-4d68-bffa-ed81d0a7bafc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perifit
• Version Model Number: Pink Perifit
• Company DUNS: 264648644
• Company Name: X6 INNOVATIONS
• 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: 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	03770014642448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221476

FDA Product Code

• HIR: Perineometer

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: 2023-05-22
• Device Publish Date: 2023-05-12

On-Brand Devices [Perifit]

• 07109615470598: Perifit Kegel Exerciser with App
• 03770014642226: Perifit Kegel Exerciser with App
• 03770014642004: Perifit Kegel Exerciser with App
• 03770014642660: Kegel Exerciser with App
• 03770014642448: Kegel Exerciser with App