MyndStep™ empowers you towards independence. People with foot drop have difficulty lifting the front part of their foot, which leads them to drag their toes. This causes them to walk slowly and easily trip over.
MyndStep™ is a functional electrical stimulation (FES) system indicated for the treatment for foot drop secondary to an upper motor neuron (UMN) injury to include and not limited to:
- Stroke,
- Spinal Cord Injury (SCI),
- Traumatic Brain Injury (TBI),
- Multiple Sclerosis (MS), and
- Cerebral Palsy (CP)
MyndStep™ is equipped with two convenient modes for use with programmable stimulation modes depending on patients’ injury level.
The Train Mode
Training Mode can be used for motor re-education while in a sitting or supine position.
Training mode will address:
- trophic changes in muscle tissue, soft tissue, and skin;
- muscle atrophy;
- maintain and improve range of motion;
- neuromodulation of abnormal muscle tone;
- promotion of muscle pumping action to facilitate venous and lymphatic circulation;
- increase local blood for the healthy support of soft tissue and nerve integrity; and
- risk for skin breakdown/wound.
The Walk Mode
Walking Mode – Electrical stimulation via electrodes will stimulate nerves to create muscle contractions. The stimulated muscles create the dorsi-flexion of the foot and toes/ lifting of the forefoot and toes. The Walk Mode promotes the re-education and neuro-control with gait training.
Features
- Small and portable device with magnetic electrodes
- Durable, rechargeable Li battery, USB charging port
- Wireless Bluetooth connection
- App works with smart phone or tablet
- Built-in smart sensor and real time monitoring
- Custom protocols and quantitative motion data
- Train mode & walk mode to accommodate needs
| Modes | Train Mode, Walk Mode |
|---|---|
| Output Waveform | Symmetrical biphasic pulse |
| Pulse Duration | Adjustable 50-500 μs, stepping 10 μs |
| Pulse Frequency | Adjustable |
| Intensity | 0-100 mA |
| Battery | Rechargeable Lithium Battery |
The MyndStep™is approved for use in Canada and cleared for use in the USA.
- FDA Listed (510k No. K202110)
- Health Canada (LN: 108428)
Indications for Use in USA
The MyndStep™ is intended to provide ankle dorsiflexion in individuals who have a dropped foot due to upper motor neuron injury. The device electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual’s gait. MyndStep™ may also:
- Prevent/slow disuse atrophy;
- Maintain or increase joint range of motion;
- Increase local blood flow.
Indications for Use in Canada
The MyndStep™ is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. Detect the swing phase of gait and appropriate electrical stimulation of the leg and ankle muscles may improve gait by flexing the foot of persons who have lost or impaired function.
Indications for Rehabilitation
- Motor Control – modulation of abnormal muscle tone and spasticity
- Motor Learning Enforced
- Neuroplasticity
- Pre-Gait Activities
- Early Gait Training
- Gait Training (unlevel surfaces & unlevel terrain)
- Functional Activities
Contraindications for Use in USA and Canada
- Do not use it on persons with implanted demand-type cardiac pacemakers or defibrillators.
- Do not use it on persons with severe heart failure or arrhythmia.
- Do not use if person has a history of seizure disorder.
- Do not use it on persons in the acute or critical stage of important organ disease.
- Do not use it on persons who cannot provide sensory feedback for stimulation (unable to express or have difficulty in the communication), such as mental disease.
- Do not place the electrodes on the carotid sinus region.
- Do not place the electrodes over the eyes, pregnant women’s waist or abdomen or other specific areas.
- Do not use it on persons whose treatment area with bleeding tendency, metal matter or tuberculous lesions.
- Do not place the electrodes over areas in which symptoms of existing thrombosis or thrombophlebitis are present.
- Do not place the electrodes over areas with acute suppurative inflammation symptoms.
- Do not place the electrodes over areas of skin allergy, infection, rash, wound or scars.
- Do not place the electrodes over malignant tumors.
- Do not place the electrodes over areas of fracture or dislocation.
- Other specific conditions or diseases that doctors deem at risk.
For more information on Contraindications for Use and Safety Precautions, please refer to your MyndStep™ User Guide.
Resources
FAQs
The below warranty policy is for the MyndStep system.
Any unauthorized modifications or repairs will void this warranty. All repairs to the equipment must be performed by an authorized service center or the manufacturer.
Warranty for the main unit
- This warranty shall remain in effect for two years (24 months) from the product’s delivery date to the end customer. If the equipment fails to function during the warranty period due to a defect in material or workmanship, the manufacturer will repair it without charge. The warranty does not extend to wear parts.
- To validate the warranty, please complete the Warranty Card and send it with the copy of the original invoice to the email address info@myndtec.com within 7 working days of purchase.
Warranty for the accessories (power adapter, leg brace and lithium battery)
- The warranty period of the accessories (power adapter, leg brace and lithium battery) is 12 months (1 year) from the date of delivery of the product to the end customer.
- If the accessories (power adapter, leg brace and lithium battery) fail to function during the warranty period due to a defect in material or workmanship, at the manufacturer’s option, the manufacturer or 84 the authorized dealer will repair this product without charge. Damages due to non-adherence to the User Manual are excluded from the warranty.
This Warranty Does Not Cover:
- Replacement parts or labor furnished by anyone other than the manufacturer, the authorized dealer or a certified company service technician.
- Defects or damage caused by labor furnished by someone other than the manufacturer, the authorized dealer or a certified company service technician.
- Any malfunction or failure in the product caused by product misuse, including, but not limited to, the failure to provide reasonable and necessary maintenance or any use that is inconsistent with the User Manual.
MyndTec Inc. has a flexible return policy for the MyndStep system.
We offer a full refund with no restocking fees if the conditions specified below are met:
- Items must be received within 30 days of date of purchase
- Items must be in a resalable condition*
- Returns must include ALL original items, packaging, and instructions
A restocking fee may be deducted from your refund if the conditions specified applies to the return:
- Items original packing has shipping labels or writing placed by the customer
- Items vital information or accessories or products are missing or damaged
The customer is held responsible for covering any return shipping costs. Please keep a copy of any tracking information for proof of delivery and for your records.
*Goods to be returned must be in salable condition. Salable condition is defined as product in original shipping condition encased in a plastic seal. The FDA prohibits the reuse of devices prescribed as a single patient unit. Custom or altered products are not returnable.
To return an item, please email info@myndtec.com to confirm the (1) product, (2) part number and/or serial number, (3) reason for return. Provided the required conditions are met, you will receive a Return Goods Authorization (RGA) number that should be referenced on the return shipment.
- All products returned with a claim of a manufacturer’s defect by the customer are subject to the terms & conditions in the MyndStep™warranty policy.
- Any products over 30 days from invoice date are non-returnable, unless otherwise noted.
Please make note that returning an item to any address other than 1900 Minnesota Court, Suite 122, Mississauga, Ontario, L5N 3C9, can cause delays.
Please be advised that Returns/Credits can take up to 6 weeks for processing.
Please contact MyndTec toll free at 1-888-363-0581.
