EMFACE controller

GUDID B108785APMMUS00

BTL INDUSTRIES LIMITED

Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system Multi-modality hyperthermia system

• Primary Device ID: B108785APMMUS00
• NIH Device Record Key: b859c82a-7c93-4543-896a-93e4d3c1da68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMFACE controller
• Version Model Number: BTL-785-7
• 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	B108785APMMUS00 [Primary]

FDA Product Code

• PBX: Massager, Vacuum, Radio Frequency Induced Heat

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: 2022-08-16
• Device Publish Date: 2022-08-08

On-Brand Devices [EMFACE controller]

• B108785APMMUS00: BTL-785-7
• B108785APMMUS10: BTL-785-7