H200 Wireless System

GUDID 00815962020511

Cloth Electrodes

BIONESS INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00815962020511
• NIH Device Record Key: 67f3a358-5eda-45be-96c3-b8a4b27d0547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H200 Wireless System
• Version Model Number: H2W-5D00
• Company DUNS: 182287727
• Company Name: BIONESS INC.
• 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: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com
• Phone: +1(800)211-9136
• Email: info@bioness.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815962020511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123636

FDA Product Code

• GZI: STIMULATOR, NEUROMUSCULAR, EXTERNAL FUNCTIONAL

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: 2019-06-24
• Device Publish Date: 2019-06-14

On-Brand Devices [H200 Wireless System]

• 00815962020511: Cloth Electrodes
• 00815962020603: H200 Wireless Clinician Upgrade Kit
• 00815962020597: H200 Wireless System Kit, Left (Small)
• 00815962020580: H200 Wireless System Kit, Right (Small)
• 00815962020573: H200 Wireless Clinician Kit, Large
• 00815962020566: H200 Wireless Clinician Kit, Small / Medium
• 00815962020559: H200 Wireless System Kit, Left (Large)
• 00815962020542: H200 Wireless System Kit, Right (Large)
• 00815962020535: H200 Wireless System Kit, Left (Medium)
• 00815962020528: H200 Wireless System Kit, Right (Medium)