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 ID00850998008539
NIH Device Record Key4ee4786e-3daa-4617-a5c0-70ed4a5911d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameManaFlexx 2 Electrodes - 10 pack
Version Model NumberMFELP10
Catalog NumberMFELP10
Company DUNS084042331
Company NameManamed, Inc.
Device Count40
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com
Phone888-508-0712
Emailsupport@manamed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810113683232 [Primary]
GS100850998008539 [Unit of Use]

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-29
Device Publish Date2025-08-21

Devices Manufactured by Manamed, Inc.

00850998008539 - ManaFlexx 2 Electrodes - 10 pack2025-08-29ManaFlexx 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
00850998008539 - ManaFlexx 2 Electrodes - 10 pack2025-08-29 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 h
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00850998008348 - ManaMed Inc2024-07-11 Reusable universal compression thigh, knee, and upper calf garment; increases venous blood flow to help prevent deep vein thromb

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