Element System with IBT Electrodes

GUDID 00850004850008

Surface electrodes for Electromyography with controller - Coaxial Plug or Ottobock Wrist

INFINITE BIOMEDICAL TECHNOLOGIES, LLC

Myoelectric hand prosthesis

• Primary Device ID: 00850004850008
• NIH Device Record Key: 979c5d2a-0f4e-415c-bbbf-0ff079cebe37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Element System with IBT Electrodes
• Version Model Number: 80101-1
• Company DUNS: 037376022
• Company Name: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• Device Count: 1
• DM Exempt: true
• 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: false
• 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: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com
• Phone: 4434517175
• Email: support@i-biomed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850004850008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173571

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2021-03-03
• Device Publish Date: 2021-02-23

On-Brand Devices [Element System with IBT Electrodes]

• 00850004850022: Surface electrodes for Electromyography with controller - Dynamic Arm
• 00850004850008: Surface electrodes for Electromyography with controller - Coaxial Plug or Ottobock Wrist