MyndStep

Primary DI
00692520001027
Brand
MyndStep
Company
MyndTec Inc
Model
MyndStep Foot Drop Stimulator
Catalog number
800102
Device description
MyndStep is a wearable foot drop device, which comprises by stimulator unit, MyndStep APP, electrode lead wire, electrodes and leg brace. It can control the timing and duration of the stimulation by tracing the angle during walking. It uses FES (functional electrical stimulation) to treat and improve the patient's foot drop to help the patient improve their walking ability.
Published
2022-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K202110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202110000MStim Drop Model: LGT-233Guangzhou Longest Science & Technology Co., Ltd.2021-11-05GZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00692520001027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00692520001027006925200010276925200010270692520001027

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
203019245
Device count
1
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
00692520002000MyndMoveMyndMove FES System9002002019-12-11
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

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Primary DI, Brand, Company table
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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
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