H200 Wireless

GUDID 00810188050601

Clinician Programmer Software for H200 Wireless System

Bioness Medical, Inc.

Hand orthosis

• Primary Device ID: 00810188050601
• NIH Device Record Key: 797adf1c-e506-44c2-8789-54d1178b4c46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H200 Wireless
• Version Model Number: H2W-SW01
• Company DUNS: 119378513
• Company Name: Bioness Medical, 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@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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810188050601 [Primary]
GS1	00815962020290 [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

Devices Manufactured by Bioness Medical, Inc.

• 00810188050014 - Vector Gait and Safety System: 2025-07-28 Vector Gait and Safety System, Elite Model
• 00810188050021 - Bioness Integrated System (BITS) Bedside Configuration: 2025-07-28 Bioness Integrated Therapy System, Version 2.0, Bedside Configuration, 24" Display with Software
• 00810188050045 - Bioness Integrated Therapy System, BITS 3.0, BITS Balance: 2025-07-28 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit
• 00810188050052 - L360 Thigh System: 2025-07-28 L360 Thigh System Kit, Right
• 00810188050083 - L300 Go System: 2025-07-28 L300 Go System, Left Lower
• 00810188050120 - L300 Go System: 2025-07-28 L300 Go System, Left Thigh Plus
• 00810188050175 - L100 Go System: 2025-07-28 L100 Go System, Left
• 00810188050274 - L300 Go System: 2025-07-28 Quick Fit Electrode, Right