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Mobile Arm Rehabilitation Kit (MARK)

Myomo, Inc. · Model MARK 26215 · UDI-DI 00855846007122

HCC IQI IRE IQZ Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

108

Facilities

Description

The Mobile Arm Rehabilitation Kit (MARK) 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 MARK 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.

Recalls

Date	Firm	Reason
2023-12-11	RONAN MEDICAL LLC	Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.
2017-07-07	Ondamed Inc	The firm was marketing the Ondamed System in the US without marketing clearance. As a corrective action, the firm revised its device design to comply with regulations. The firm has
2015-10-01	Powers Medical Devices, LLC	PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k).
2012-11-15	EEG Info	EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.