MyndMove

Basic Information

• Brand Name: MyndMove
• Primary DI: 00692520001263
• Version / Model: MyndMove Electrode Cable Violet
• Catalog Number: 900126
• Company Name: MyndTec Inc
• Labeler DUNS: 203019245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-11
• Public Version: 1
• Public Version Date: 2019-12-19
• Public Version Status: New
• Public Device Record Key: 75a94b02-974b-48a3-98cd-9940deac4f05

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: MR Unsafe
• Direct Marking Exempt: No
• 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
IPF	Stimulator, Muscle, Powered	Physical Medicine	890.5850	2
GZI	Stimulator, Neuromuscular, External Functional	Neurology	882.5810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59690	Neuromuscular transmission electrode/sensor lead	A non-sterile insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (NMT) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation to determine the level of neuromuscular block and the localization of a nerve in an area of the body. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00692520001263	GS1
Previous	06925209001266	GS1

Premarket Submissions

Submission Number	Supplement Number
K170564	000