Hinge Health Pelvic Trainer by Perifit

GUDID 03770014642486

Kegel Exerciser

X6 INNOVATIONS

Pelvic floor muscle exerciser

• Primary Device ID: 03770014642486
• NIH Device Record Key: f12913a5-ec00-422e-adf8-a1dbd31632fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hinge Health Pelvic Trainer by Perifit
• Version Model Number: 900-00110
• 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	03770014642486 [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: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by X6 INNOVATIONS

• 03770014642233 - Perifit Pump: 2024-03-18
• 03770014642264 - Perifit Pump: 2024-03-18
• 03770014642271 - Perifit Pump: 2024-03-18
• 03770014642288 - Perifit Pump: 2024-03-18
• 03770014642295 - Perifit Pump: 2024-03-18
• 03770014642486 - Hinge Health Pelvic Trainer by Perifit: 2024-01-23Kegel Exerciser
• 03770014642486 - Hinge Health Pelvic Trainer by Perifit: 2024-01-23 Kegel Exerciser
• 03770014642196 - Perifit Care+: 2024-01-12 Kegel Exerciser with App
• 03770014642134 - Perifit Care: 2023-05-22 Kegel Exerciser with App