ManaFlexx 2 Electrodes - 10 pack MFELP10

GUDID 00850998008539

ManaFlexx 2 is the only NMES device designed for ease of use. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions Completely portable Can be placed anywhere treatment is desired Battery operated Reusable - simply replace pads and batteries

Manamed, Inc.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00850998008539
• NIH Device Record Key: 4ee4786e-3daa-4617-a5c0-70ed4a5911d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManaFlexx 2 Electrodes - 10 pack
• Version Model Number: MFELP10
• Catalog Number: MFELP10
• Company DUNS: 084042331
• Company Name: Manamed, Inc.
• Device Count: 40
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113683232 [Primary]
GS1	00810113683485 [Primary]
GS1	00850998008539 [Unit of Use]

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2025-08-29
• Device Publish Date: 2025-08-21

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