Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MyndMove 2.0

K-Number: K212149 · 2022-03-03

ApplicantMyndtec, Inc.
Decision Date2022-03-03
Product CodeGZI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MyndMove 2.0 is a medical device manufactured by Myndtec, Inc.. It received FDA 510(k) clearance on 2022-03-03 under approval number K212149. 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 2.0?

MyndMove 2.0 is a medical device that received FDA 510(k) clearance on 2022-03-03. It is manufactured by Myndtec, Inc.. The 510(k) number is K212149.

When was MyndMove 2.0 approved by the FDA?

MyndMove 2.0 received FDA 510(k) clearance on 2022-03-03, under approval number K212149.

What company makes MyndMove 2.0?

MyndMove 2.0 is manufactured by Myndtec, Inc..

What is the FDA product code for MyndMove 2.0?

The FDA product code for MyndMove 2.0 is GZI.

Other Devices by Myndtec, Inc.

K170564MyndMove System, MyndMove Functional Electrical Stimulator K233006MyndMove, MyndMove 2.0

Related Devices (Code: GZI)

K153163ReGraspRehabtronics, Inc. K162718Foot Drop System (Model XFT-2001D)Shenzhen Xft Medical Limited K170564MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc. K162470RT300 FES cycle ergometerRestorative Therapies, Inc. K170132MyoCycle Home, MyoCycle ProMyolyn, LLC K162683RehaStim 2Hasomed GmbH

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.

↑