MyoPro 2x 29858

GUDID 00855846007221

The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro 2x consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2x EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2x filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2x to assist the User to initiate and complete desired motions.

Myomo, Inc.

Psychophysiological biofeedback system

• Primary Device ID: 00855846007221
• NIH Device Record Key: 563918a9-62d4-4d94-beb8-1980b3ebfbc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoPro 2x
• Version Model Number: Motion G Right - 29858 rev1
• Catalog Number: 29858
• Company DUNS: 148053676
• Company Name: Myomo, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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	00855846007221 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2024-11-11
• Device Publish Date: 2024-09-20

On-Brand Devices [MyoPro 2x]

• 00855846007184: The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened
• 00855846007177: The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened
• 00855846007221: The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened
• 00855846007214: The MyoPro 2x, an upper extremity limb orthosis, is an assistive device that supports a weakened