MyndMove

Basic Information

• Brand Name: MyndMove
• Primary DI: 00692520001690
• Version / Model: MyndMove Electrode 3cm x 1cm
• Catalog Number: 900169
• 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: 43d1501b-f2e9-46f1-aaf2-15a9534edb72

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
59689	Neuromuscular transmission electrode	A non-sterile electrical conductor designed to be applied to a patient's body surface, typically the forearm or ankle, to deliver stimulating electrical pulses to a motor nerve or measure electrical impulses from the nerve during neuromuscular transmission (NMT) monitoring. It is typically a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled) intended to be used for neuromuscular block monitoring and nerve stimulation for brachial plexus anaesthesia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00692520001690	GS1
Previous	06925209001693	GS1

Premarket Submissions

Submission Number	Supplement Number
K170564	000