MyndMove 2.0 920200

GUDID 00692520202004

MyndTec Inc

Neuromuscular transmission electrode

• Primary Device ID: 00692520202004
• NIH Device Record Key: f9e26be1-b99a-42e8-9c54-092f2cc8fde0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyndMove 2.0
• Version Model Number: MyndMove FES System
• Catalog Number: 920200
• Company DUNS: 203019245
• Company Name: MyndTec Inc
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	00692520202004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212149

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: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [MyndMove 2.0]

• 00692520202004: MyndMove FES System
• 00692520201656: MyndMove FES Stimulator