Mobile Arm Rehabilitation Kit version 2 (MARK2) MARK2 29860

GUDID 00855846007191

The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) MyoPro upper extremity limb orthoses. A MyoPro 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 MARK2 product consists of a combination of the following components: shoulder harnesses, adjustable limb orthoses (braces), powered elbow orthoses with surface electromyography (EMG) sensors, static or manually set multi-articulating wrists (MAW), static hand orthoses or powered hand orthoses with EMG sensors, an interchangeable battery with a separate recharging station, an MTS chafe with loop for anti-rotation strap, a laptop, and a product carrying case/bag. The MyoPro’s EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. A MyoPro device 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 to assist the User to initiate and complete desired motions.

Myomo, Inc.

Psychophysiological biofeedback system

• Primary Device ID: 00855846007191
• NIH Device Record Key: 39715f2b-84fb-45df-a0bf-bb922f195be9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mobile Arm Rehabilitation Kit version 2 (MARK2)
• Version Model Number: MARK2 29860
• Catalog Number: MARK2 29860
• 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	00855846007191 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

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: 2024-10-21
• Device Publish Date: 2024-10-11

On-Brand Devices [Mobile Arm Rehabilitation Kit version 2 (MARK2)]

• 00855846007191: The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) Myo
• 00855846007238: The Mobile Arm Rehabilitation Kit version 2 (MARK2) is a kit containing two (left and right) Myo