H200 Wireless System

Basic Information

• Brand Name: H200 Wireless System
• Primary DI: 00815962020511
• Version / Model: H2W-5D00
• Company Name: BIONESS INC.
• Labeler DUNS: 182287727
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-14
• Public Version: 4
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: 67f3a358-5eda-45be-96c3-b8a4b27d0547

Device Description

Cloth Electrodes Set

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: Yes
• 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
IPF	Stimulator, muscle, powered	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65318	Transcutaneous electrical stimulation electrode, reusable	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815962020511	GS1

Customer Contacts

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