Hinge Health Pelvic Trainer by Perifit

GUDID 03770014642486

Kegel Exerciser

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 Pelvic floor muscle exerciser 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