BTL EMSELLA

GUDID B108D099PO130ENUS1030

BTL INDUSTRIES LIMITED

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional Deep-tissue electromagnetic stimulation system, professional

• Primary Device ID: B108D099PO130ENUS1030
• NIH Device Record Key: f26b6317-ac83-4f31-994b-ce8a8ed4db1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BTL EMSELLA
• Version Model Number: BTL EMSELLA
• Company DUNS: 733532951
• Company Name: BTL INDUSTRIES LIMITED
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B108D099PO130ENUS1030 [Primary]

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: 2019-03-11
• Device Publish Date: 2019-02-25

On-Brand Devices [BTL EMSELLA]

• B108D099PO130ENUS1030: BTL EMSELLA
• B108D099PO130ENUS1020: BTL EMSELLA