Myomo Inc. is a FDA Registered medical device company with its MyoPro family of products, which includes the current MyoPro 2x device as a Listed FDA Class-2, 510-K exempt device. Our medical devices are produced under the Medical Device Single Audit Program (MDSAP), a Quality Management System (QMS) certification to which FDA subscribes. Myomo’s FDA registration can be found here.
The MyoPro 2x, an upper limb orthosis, is a compensatory device to increase ability to perform functional tasks with the affected limb. The user voluntarily activates movement of the orthotic device with their remaining electromyography (EMG) muscle signal.
The MyoPro 2x is indicated for use by adolescents and adults diagnosed with long-term muscle weakness OR partial paralysis. Users must meet physical size specifications and demonstrate capacity to use the device, including sufficient cognitive abilities, per user assessment and clinician evaluation.
The MyoPro 2x is contraindicated for use as follows:
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Myomo, Inc. is the owner of registered trademarks Myomo and MyoPro.
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