Perifit

GUDID 03770014642448

Kegel Exerciser with App

X6 INNOVATIONS

Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser Pelvic floor muscle exerciser 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