H200 Wireless System

GUDID 00810188050359

H200 Wireless System Kit, Left (Small)

Bioness Medical, Inc.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00810188050359
• NIH Device Record Key: 5e66bd4a-019a-49d3-8f21-4bb361a1d479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H200 Wireless System
• Version Model Number: H2W-5000
• Company DUNS: 119378513
• Company Name: Bioness Medical, Inc.
• 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: true
• 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

Customer Support Contacts

• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com
• Phone: +1(800)211-9136
• Email: info@bionessmedical.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810188050359 [Primary]
GS1	00815962020597 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111767

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: 2025-07-25
• Device Publish Date: 2025-07-17

On-Brand Devices [H200 Wireless System]

• 00810188050434: H200 Wireless Clinician Upgrade Kit
• 00810188050427: H200 Wireless Clinician Kit, Large
• 00810188050410: H200 Wireless Clinician Kit, Small / Medium
• 00810188050403: H200 Wireless System Kit, Right (Large)
• 00810188050397: H200 Wireless System Kit, Left (Large)
• 00810188050380: H200 Wireless System Kit, Right (Medium)
• 00810188050373: H200 Wireless System Kit, Left (Medium)
• 00810188050366: H200 Wireless System Kit, Right (Small)
• 00810188050359: H200 Wireless System Kit, Left (Small)
• 00810188050441: Cloth Electrodes Set