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Sign in to claim this brandMyndtec, Inc.
US
Last updated May 23, 2026
What Myndtec, Inc. makes
Myndtec, Inc. manufactures transcutaneous neuromuscular electrical stimulation (NMES) systems designed for physical therapy applications. These devices include neuromuscular transmission electrodes and sensor leads, used to facilitate muscle activation and rehabilitation. The portfolio includes multiple iterations of the MyndMove system, as well as the MyndStep device, which likely targets gait training or lower-limb recovery.
The company’s neuromuscular stimulation devices are classified as Class II under FDA regulations, requiring premarket notification (510(k)) or unique device identification (UDI) listing. These products are authorised for commercial distribution in the United States, where the manufacturer is based. No additional regulatory registries outside the FDA framework are referenced.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Myndtec, Inc. manufacture?
Myndtec, Inc. specializes in transcutaneous neuromuscular electrical stimulation (NMES) systems for physical therapy. Their portfolio includes systems like the MyndMove (used for muscle activation and rehabilitation) and the MyndStep (likely for gait training or lower-limb recovery). They also produce neuromuscular transmission electrodes and sensor leads, which are components used alongside these systems to deliver targeted electrical stimulation.
Where is Myndtec, Inc. based, and where are their devices authorised for use?
Myndtec, Inc. is headquartered in the United States. Their neuromuscular stimulation devices are authorised for commercial distribution in the U.S. under FDA regulations, which govern their classification and listing requirements.
How are Myndtec’s devices classified under FDA regulations, and why does this matter?
Myndtec’s neuromuscular stimulation devices fall under Class II classification by the FDA. This classification means they require premarket notification (510(k)) or unique device identification (UDI) listing before being marketed. Class II devices are considered to have moderate risk and require special controls beyond general controls to ensure safety and effectiveness, which is why they must comply with these regulatory pathways.
Which regulatory registries or databases list Myndtec’s devices?
Myndtec’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries track authorised medical devices in the U.S. to ensure compliance with FDA requirements. No additional regulatory registries outside the FDA framework are referenced for their products.
Why do Myndtec’s devices require FDA premarket notification or UDI listing?
Because Myndtec’s neuromuscular stimulation devices are Class II under FDA regulations, they are subject to special controls that require either a 510(k) premarket notification (to demonstrate substantial equivalence to a predicate device) or UDI listing (to ensure traceability and transparency in the supply chain). These requirements help ensure the devices meet safety and performance standards before entering the market.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 203019245
Catalogue (54)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MyndMove | MyndMove Electrode 5cm x 5cm | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Security Tape 2.5 cm | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Red | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode 2.5 D | FDA UDI | Class II | Unknown |
| MyndStep | MyndStep Self-Adhesive Electrode with Magnetic Connection | FDA UDI | Class II | Active |
| MyndMove | MyndMove Functional Electrical Stimulator | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Splitter Cable | FDA UDI | Class II | Active |
| MyndMove | MyndMove Security Tape 2.5 cm | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode 9cm x 5cm | FDA UDI | Class II | Active |
| MyndMove | MyndMove FES Stimulator | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Yellow | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode Cable Yellow | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Violet | FDA UDI | Class II | Active |
| MyndMove | MyndMove Foot Switch | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove FES System | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Hand Switch | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Orange | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Green | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Brown | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Foot Switch | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode 9cm x 5cm | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode Cable Pack | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode Cable Violet | FDA UDI | Class II | Unknown |
| MyndStep | MyndStep Foot Drop Stimulator | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode 2.5 D | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Black | FDA UDI | Class II | Active |
| MyndMove | MyndMove Functional Electrical Stimulator | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Security Tape 7.5 cm | FDA UDI | Class II | Active |
| MyndStep | MyndStep Foot Drop Brace | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Brown | FDA UDI | Class II | Active |
| MyndMove | MyndMove FES System | FDA UDI | Class II | Active |
| MyndStep | MyndStep Lead Wire | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Blue | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode 3cm x 1cm | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode Cable Grey | FDA UDI | Class II | Active |
| MyndMove 2.0 | MyndMove FES System | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Black | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Mobile Cart | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode 5cm x 5cm | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode 3cm x 1cm | FDA UDI | Class II | Active |
| MyndMove | MyndMove FES System | FDA UDI | Class II | Active |
| MyndMove | MyndMove Security Tape 7.5 cm | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode Cable Green | FDA UDI | Class II | Unknown |
| MyndMove 2.0 | MyndMove FES Stimulator | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Blue | FDA UDI | Class II | Active |
| MyndMove | MyndMove Functional Electrical System | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Hand Switch | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove FES Stimulator | FDA UDI | Class II | Active |
| MyndMove | MyndMove Electrode Cable Orange | FDA UDI | Class II | Unknown |
| MyndMove | MyndMove Electrode Cable Red | FDA UDI | Class II | Unknown |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Myndtec Inc Mississauga Ontario · CA FEI 3013927823