Payer Resource Center

FDA Registration & Listing / IFU

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.

Intended Use

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.

Indications for Use

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.

Contraindications

The MyoPro 2x is contraindicated for use as follows:

  1. Insufficient myoelectric signal output from at least one muscle group needed to activate the desired powered joint (for example, biceps or triceps signal to extend the affected elbow).
  2. Severe shoulder subluxation.
  3. Excessive pain in shoulder, arm or hand during facilitated range of motion.
  4. Contraindicated during recovery from acute injury such as trauma, infection, or skin condition.
  5. Upper extremity contracture(s) that prevent functional movement to benefit from the orthosis.
  6. Rigid spasticity in the affected muscle groups.
  7. Arm circumferences and lengths that are outside build specifications required to be fit with the orthosis.
  8. Cognitive or behavioral impairment that would inhibit safe use of the orthosis.
  9. Other medical issue which interferes with safe use of the device for functional improvement.