MyndStep 800112

GUDID 00692520001126

MyndTec Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00692520001126
• NIH Device Record Key: 95aa488e-084c-46c6-a163-c986debc0d00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyndStep
• Version Model Number: MyndStep Foot Drop Brace
• Catalog Number: 800112
• Company DUNS: 203019245
• Company Name: MyndTec Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• 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	00692520001126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202110

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-02
• Device Publish Date: 2022-09-16

On-Brand Devices [MyndStep]

• 00692520001133: MyndStep Lead Wire
• 00692520001126: MyndStep Foot Drop Brace
• 00692520001119: MyndStep Self-Adhesive Electrode with Magnetic Con
• 00692520001027: MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, elect