MyndMove 910165

GUDID 00692520101659

MyndTec Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00692520101659
• NIH Device Record Key: d8198a2a-2845-466d-83c6-ae76ad07a76f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyndMove
• Version Model Number: MyndMove FES Stimulator
• Catalog Number: 910165
• Company DUNS: 203019245
• Company Name: MyndTec Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00692520101659 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170564

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-19
• Device Publish Date: 2019-12-11

On-Brand Devices [MyndMove]

• 06925209102000: MyndMove Functional Electrical System
• 06925209101652: MyndMove Functional Electrical Stimulator
• 06925209003048: MyndMove Security Tape 7.5 cm
• 06925209003031: MyndMove Security Tape 2.5 cm
• 06925209002003: MyndMove FES System
• 06925209001693: MyndMove Electrode 3cm x 1cm
• 06925209001686: MyndMove Electrode 2.5 D
• 06925209001679: MyndMove Electrode 5cm x 5cm
• 06925209001662: MyndMove Electrode 9cm x 5cm
• 06925209001655: MyndMove FES Stimulator
• 06925209001570: MyndMove Hand Switch
• 06925209001457: MyndMove Foot Switch
• 06925209001365: MyndMove Splitter Cable
• 06925209001273: MyndMove Electrode Cable Orange
• 06925209001266: MyndMove Electrode Cable Violet
• 06925209001259: MyndMove Electrode Cable Brown
• 06925209001242: MyndMove Electrode Cable Green
• 06925209001235: MyndMove Electrode Cable Yellow
• 06925209001228: MyndMove Electrode Cable Blue
• 06925209001211: MyndMove Electrode Cable Red
• 06925209001204: MyndMove Electrode Cable Black
• 06925209001037: MyndMove Electrode Cable Pack
• 00692520102007: MyndMove FES System
• 00692520101659: MyndMove FES Stimulator
• 00692520003045: MyndMove Security Tape 7.5 cm
• 00692520003038: MyndMove Security Tape 2.5 cm
• 00692520001690: MyndMove Electrode 3cm x 1cm
• 00692520001683: MyndMove Electrode 2.5 D
• 00692520001676: MyndMove Electrode 5cm x 5cm
• 00692520001669: MyndMove Electrode 9cm x 5cm
• 00692520001577: MyndMove Hand Switch
• 00692520001454: MyndMove Foot Switch
• 00692520001362: MyndMove Splitter Cable
• 00692520001270: MyndMove Electrode Cable Orange
• 00692520001263: MyndMove Electrode Cable Violet
• 00692520001256: MyndMove Electrode Cable Brown
• 00692520001249: MyndMove Electrode Cable Green
• 00692520001232: MyndMove Electrode Cable Yellow
• 00692520001225: MyndMove Electrode Cable Blue
• 00692520001218: MyndMove Electrode Cable Red
• 00692520001201: MyndMove Electrode Cable Black
• 00692520001379: MyndMove Electrode Cable Grey
• 00692520202769: MyndMove Mobile Cart