SenseRx -- Anal/Small Vaginal and Vaginal EMG 4510C

GUDID 08519520070063

Perineometer -- SenseRx -- Anal/Small Vaginal and Vaginal EMG

PERSONAL MEDICAL CORP.

Perineometer

• Primary Device ID: 08519520070063
• NIH Device Record Key: 4c2612d0-c5ad-43f7-857a-83eb6c00e8f4
• Commercial Distribution Discontinuation: 2025-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SenseRx -- Anal/Small Vaginal and Vaginal EMG
• Version Model Number: 4510C
• Catalog Number: 4510C
• Company DUNS: 078511333
• Company Name: PERSONAL MEDICAL CORP.
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 425-242-6373
• Email: info@personalmed.com
• Phone: 425-242-6373
• Email: info@personalmed.com
• Phone: 425-242-6373
• Email: info@personalmed.com
• Phone: 425-242-6373
• Email: info@personalmed.com
• Phone: 425-242-6373
• Email: info@personalmed.com
• Phone: 425-242-6373
• Email: info@personalmed.com
• Phone: 425-242-6373
• Email: info@personalmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08519520070063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002834

FDA Product Code

• HIR: Perineometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2025-12-31
• Device Publish Date: 2016-12-06

Devices Manufactured by PERSONAL MEDICAL CORP.

• 08519520070009 - IVS-2: 2025-12-31 EMG Sensor
• 08519520070010 - MEP: 2025-12-31 EMG Sensor
• 08519520070018 - EvaCare Pessary: 2025-12-31 Pessary, Vaginal. Dish Pessary is used to relieve stress incontinence and minor degrees of prolapse.
• 08519520070025 - EvaCare Pessary: 2025-12-31 Pessary, Vaginal. Cube pessary is designed for third degree prolapse, cystocele and rectocele.
• 08519520070063 - SenseRx -- Anal/Small Vaginal and Vaginal EMG: 2025-12-31Perineometer -- SenseRx -- Anal/Small Vaginal and Vaginal EMG
• 08519520070063 - SenseRx -- Anal/Small Vaginal and Vaginal EMG: 2025-12-31 Perineometer -- SenseRx -- Anal/Small Vaginal and Vaginal EMG
• 08519520070070 - IVS-2: 2025-12-31 EMG Sensor
• 08519520070087 - MEP: 2025-12-31 EMG Sensor
• 08519520070148 - EvaCare Pessary: 2025-12-31 Pessary, Vaginal. Gellhorn pessary is used for a second to third degree prolapse, or procidentia.