NeuroField X3000

Basic Information

• Brand Name: NeuroField X3000
• Primary DI: 00860410000300
• Version / Model: 17
• Company Name: NEUROFIELD, INC.
• Labeler DUNS: 948497578
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-25
• Public Version: 3
• Public Version Date: 2020-03-31
• Public Version Status: Update
• Public Device Record Key: edb95b96-d4a7-45ae-bb5b-f849ffbf2cb5

Device Description

Pulsed Electromagnetic Field (pEMF) generator for use with NeuroField Software Suite. Stimulation unit for low-intensity neurofeedback.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
63313	Kinesiology/electromyographic sensor set	A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860410000300	GS1

Customer Contacts

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