MyndMove

Basic Information

• Brand Name: MyndMove
• Primary DI: 06925209001693
• Version / Model: MyndMove Electrode 3cm x 1cm
• Catalog Number: 900169
• Company Name: MyndTec Inc
• Labeler DUNS: 203019245
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-24
• Public Version: 6
• Public Version Date: 2020-10-02
• Public Version Status: Update
• Public Device Record Key: 45525fcb-4522-4893-86e6-a1a6ddf6a3f1
• Distribution End Date: 2019-09-23

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	06925209001693	GS1

Premarket Submissions

Submission Number	Supplement Number
K170564	000