FDA.reportPublic FDA data

MyndMove

Primary DI
00692520002000
Brand
MyndMove
Company
MyndTec Inc
Model
MyndMove FES System
Catalog number
900200
Published
2019-12-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional
IPFStimulator, Muscle, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZIStimulator, Neuromuscular, External FunctionalNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170564000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06925209002003PreviousGS10
00692520002000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
06925209002003069252090020036925209002003
00692520002000006925200020006925200020000692520002000

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly 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.

Regulatory Flags#

DUNS number
203019245
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00692520001652MyndMoveMyndMove FES Stimulator9001652019-12-11
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
00692520202769MyndMove MyndMove Mobile Cart9202762022-08-19
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
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808116actiTENSSUBLIMEDIPF2026-05-27
03770018808253actiTENS MiniSUBLIMEDIPF2026-05-27
03770018808260actiTENS MiniSUBLIMEDIPF2026-05-27
08809308380041Talent-pro Electromagnetic StimulatorREMED Co.,Ltd.IPF2026-05-13
07898966442551IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
07898966442698IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIPF2026-04-22
08032625824480GLOBUSDOMINO SRLIPF2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareIPF2026-02-06
00810140062680RENPHOJoicom CorporationIPF2025-10-20
00810140062697RENPHOJoicom CorporationIPF2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.IPF2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.IPF2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.IPF2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.IPF2025-09-11
00810113683379DualPulse CompactManamed, Inc.IPF2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.IPF2025-09-11
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.IPF2025-08-21
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.IPF2025-07-21
00810188050052L360 Thigh SystemBioness Medical, Inc.IPF2025-07-18
00810188050083L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050120L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050175L100 Go SystemBioness Medical, Inc.IPF2025-07-18
00810188050274L300 Go SystemBioness Medical, Inc.GZI2025-07-18
00810188050069L360 Thigh SystemBioness Medical, Inc.GZI2025-07-17
00810188050076L300 Go SystemBioness Medical, Inc.IPF2025-07-17
00810188050090L300 Go SystemBioness Medical, Inc.GZI2025-07-17