MyoCycle Home / Home + / Pro / Pro +

GUDID 00861553000417

FES cycle ergometer

MYOLYN, LLC

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00861553000417
• NIH Device Record Key: 5130196a-d3a8-45e6-8ed8-be0e763d47a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyoCycle
• Version Model Number: MC-2
• Catalog Number: Home / Home + / Pro / Pro +
• Company DUNS: 078873484
• Company Name: MYOLYN, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com
• Phone: 3523542749
• Email: myolyn@myolyn.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861553000417 [Primary]

FDA Product Code

• GZI: Stimulator, Neuromuscular, External Functional

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-19
• Device Publish Date: 2023-09-11

Devices Manufactured by MYOLYN, LLC

• 00861553000417 - MyoCycle: 2023-09-19FES cycle ergometer
• 00861553000417 - MyoCycle: 2023-09-19 FES cycle ergometer
• 00861553000400 - MyoCycle Home/Pro: 2019-05-23 FES cycle ergometer