H200 Wireless

Basic Information

• Brand Name: H200 Wireless
• Primary DI: 00810188050601
• Version / Model: H2W-SW01
• Company Name: Bioness Medical, Inc.
• Labeler DUNS: 119378513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-17
• Public Version: 1
• Public Version Date: 2025-07-25
• Public Version Status: New
• Public Device Record Key: 797adf1c-e506-44c2-8789-54d1178b4c46

Device Description

Clinician Programmer Software for H200 Wireless System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZI	Stimulator, Neuromuscular, External Functional	Neurology	882.5810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41457	Hand orthosis	A prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus intended to be used to encompass the whole or part of the hand to support, align, prevent, or correct deformities/injuries or to improve function of the hand. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810188050601	GS1
Previous	00815962020290	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111767	000