FDA.reportPublic FDA data

MyoCycle

Primary DI
00861553000417
Brand
MyoCycle
Company
MYOLYN, LLC
Model
MC-2
Catalog number
Home / Home + / Pro / Pro +
Device description
FES cycle ergometer
Published
2023-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZIStimulator, Neuromuscular, External Functional

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861553000417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861553000417008615530004178615530004170861553000417

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

Contacts#

Phone, Email table
PhoneEmail
3523542749myolyn@myolyn.com

Regulatory Flags#

DUNS number
078873484
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861553000400MyoCycle Home/ProMC-HP-12017-05-04

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
00852184003670Motor Point Probe, Synchrony Synapse Biomedical, Inc.GZI2025-10-31
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