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FDA 510(k)

MyndMove System, MyndMove Functional Electrical Stimulator

K-Number: K170564 · 2017-08-30

ApplicantMyndtec, Inc.
Decision Date2017-08-30
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MyndMove System, MyndMove Functional Electrical Stimulator is a medical device manufactured by Myndtec, Inc.. It received FDA 510(k) clearance on 2017-08-30 under approval number K170564. The device is classified under product code GZI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MyndMove System, MyndMove Functional Electrical Stimulator?

MyndMove System, MyndMove Functional Electrical Stimulator is a medical device that received FDA 510(k) clearance on 2017-08-30. It is manufactured by Myndtec, Inc.. The 510(k) number is K170564.

When was MyndMove System, MyndMove Functional Electrical Stimulator approved by the FDA?

MyndMove System, MyndMove Functional Electrical Stimulator received FDA 510(k) clearance on 2017-08-30, under approval number K170564.

What company makes MyndMove System, MyndMove Functional Electrical Stimulator?

MyndMove System, MyndMove Functional Electrical Stimulator is manufactured by Myndtec, Inc..

What is the FDA product code for MyndMove System, MyndMove Functional Electrical Stimulator?

The FDA product code for MyndMove System, MyndMove Functional Electrical Stimulator is GZI.

Related Clinical Trials

NCT05452226 Neuromuscular Electrical Stimulation in COPD/Community Acquired Pneumonia COMPLETED NCT06998134 Toward Ubiquitous Lower Limb Exoskeleton Use in Children and Young Adults RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT07137455 EDEN Intracardiac Electrogram Recording and Classifying System ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT06561828 Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making RECRUITING

Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Myndtec, Inc.

K212149MyndMove 2.0 K233006MyndMove, MyndMove 2.0

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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