Empelvic

GUDID 00384703155015

Pelvic Floor Trainer - Male

OWEN MUMFORD USA INCORPORATED

Custom-made cushion

• Primary Device ID: 00384703155015
• NIH Device Record Key: 86d9c6f8-be36-4f08-a652-5c76af5b7e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Empelvic
• Version Model Number: SM 3155
• Company DUNS: 803401454
• Company Name: OWEN MUMFORD USA INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	00384703155015 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2025-09-01
• Device Publish Date: 2025-08-22

On-Brand Devices [Empelvic]

• 00384703155015: Pelvic Floor Trainer - Male
• 00384703150010: Pelvic Floor Trainer - Femail