iSTIM

GUDID 04719871185025

Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

Perineal orifice incontinence-control electrical stimulation system probe, reusable

• Primary Device ID: 04719871185025
• NIH Device Record Key: 381f85ed-cb1c-4c21-b79d-c9a0be329972
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSTIM
• Version Model Number: iSTIM PR-03
• Company DUNS: 657383535
• Company Name: EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871185025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161349

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

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: 2023-09-04
• Device Publish Date: 2023-08-25

On-Brand Devices [iSTIM ]

• 04719871189092: Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 04719871185131: Electrical Muscel Stimulator (EMS)
• 04719871185049: Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 04719871185025: Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 04719871184950: Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 04719871189108: Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 04719871185858: HEATING TENS
• 04719871185841: HEATING TENS/EMS