ManaFlexx 2 Lead Wires

FDA UDI

Class II (US FDA UDI)

by Manamed Llc

Identity

Trade Name: ManaFlexx 2 Lead Wires FDA UDI
Generic Name: Transcutaneous electrical stimulation lead FDA UDI
Device Name: 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 Lead wires extend the reach of the electrodes FDA UDI
Model / Reference: MF002LW FDA UDI
Description: 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 Lead wires extend the reach of the electrodes FDA UDI

Identifiers

Catalog Number: MF002LW FDA UDI
Primary DI / UDI-DI: 00810113683225 FDA UDI
FDA Product Code: NGX FDA UDI
NUH FDA UDI
NYN FDA UDI
GZJ FDA UDI
IPF FDA UDI
GMDN Term: Transcutaneous electrical stimulation lead FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5850 FDA UDI
882.5890 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Transcutaneous electrical stimulation lead

ManaFlexx 2 Lead Wires by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Manamed Llc

Sources (1)

FDA UDI a1172885-2cc7-4b39-80fa-21fc87024641 35 fields · synced May 30, 2026