FDA.reportPublic FDA data

MyndMove

Primary DI
00692520202769
Brand
MyndMove
Company
MyndTec Inc
Model
MyndMove Mobile Cart
Catalog number
920276
Published
2022-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170564000
K212149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170564000MyndMove System, MyndMove Functional Electrical StimulatorMyndtec, Inc.2017-08-30GZI
K212149000MyndMove 2.0Myndtec, Inc.2022-03-03GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00692520202769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00692520202769006925202027696925202027690692520202769

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203019245
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00692520001652MyndMoveMyndMove FES Stimulator9001652019-12-11
00692520002000MyndMoveMyndMove FES System9002002019-12-11
00692520001027MyndStepMyndStep Foot Drop Stimulator 8001022022-09-16
00692520001119MyndStepMyndStep Self-Adhesive Electrode with Magnetic Con8001112022-09-16
00692520001126MyndStepMyndStep Foot Drop Brace8001122022-09-16
00692520001133MyndStepMyndStep Lead Wire8001132022-09-16
00692520201656MyndMove 2.0MyndMove FES Stimulator9201652022-08-19
00692520202004MyndMove 2.0MyndMove FES System9202002022-08-19
00692520001454MyndMoveMyndMove Foot Switch9001452019-12-11
00692520001577MyndMoveMyndMove Hand Switch9001572019-12-11
00692520003038MyndMoveMyndMove Security Tape 2.5 cm9003032019-12-11
00692520003045MyndMoveMyndMove Security Tape 7.5 cm9003042019-12-11
00692520101659MyndMoveMyndMove FES Stimulator9101652019-12-11
00692520102007MyndMoveMyndMove FES System9102002019-12-11
06925209001457MyndMove MyndMove Foot Switch9001452017-10-24
06925209001570MyndMoveMyndMove Hand Switch9001572017-10-24
06925209001655MyndMoveMyndMove Functional Electrical Stimulator9001652018-03-20
06925209002003MyndMoveMyndMove FES System9002002018-03-20
06925209003031MyndMoveMyndMove Security Tape 2.5 cm9003032017-10-24
06925209003048MyndMove MyndMove Security Tape 7.5 cm9003042017-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970670070242XFTShenzhen XFT Medical LimitedGZI2026-04-14
06970670070259XFTShenzhen XFT Medical LimitedGZI2026-04-14
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00852184003694Electrode Cable, SingleSynapse Biomedical, Inc.GZI2025-10-31
00852184003700Electrode Cable, DualSynapse Biomedical, Inc.GZI2025-10-31
00852184003717Electrode Cable, TripleSynapse Biomedical, Inc.GZI2025-10-31
00852184003724Electrode Cable, Four Synapse Biomedical, Inc.GZI2025-10-31
00852184003762Electrode Cable KitSynapse Biomedical, Inc.GZI2025-10-31
00852184003786Sensor Boot SetSynapse Biomedical, Inc.GZI2025-10-31
00852184003793Sensor Boot - SmallSynapse Biomedical, Inc.GZI2025-10-31
00852184003809Sensor Boot - MediumSynapse Biomedical, Inc.GZI2025-10-31
00852184003816Sensor Boot - LargeSynapse Biomedical, Inc.GZI2025-10-31
00852184003649Clinical Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003656Stimulator, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003663Sensor, SynchonySynapse Biomedical, Inc.GZI2025-10-23
00852184003687Patient Kit, SynchronySynapse Biomedical, Inc.GZI2025-10-23
00852184003779Kit, Wireless Charger USA 5WSynapse Biomedical, Inc.GZI2025-10-23
00860011699309EvoWalkEvolution Devices, Inc.GZI2025-08-06
00810188050052L360 Thigh SystemBioness Medical, Inc.GZI2025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050441H200 Wireless SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050106L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050113L300 Go SystemBioness Medical, Inc.GZI2025-07-17
00810188050137L300 Go SystemBioness Medical, Inc.GZI2025-07-17