MyndStep 800102

GUDID 00692520001027

MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, electrode lead wire, electrodes and leg brace. It can control the timing and duration of the stimulation by tracing the angle during walking. It uses FES (functional electrical stimulation) to treat and improve the patient's foot drop to help the patient improve their walking ability.

MyndTec Inc

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00692520001027
• NIH Device Record Key: 0a7a6478-b624-46d8-9b59-8235ee95faad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyndStep
• Version Model Number: MyndStep Foot Drop Stimulator
• Catalog Number: 800102
• Company DUNS: 203019245
• Company Name: MyndTec Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00692520001027 [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