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ManaFlexx 2 Electrodes - 4 electrodes

FDA UDI

Class II (US FDA UDI)

by Manamed Llc

Identity

Trade Name
ManaFlexx 2 Electrodes - 4 electrodes FDA UDI
Generic Name
Transcutaneous electrical stimulation electrode, reusable 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 FDA UDI
Model / Reference
MFELP4 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 FDA UDI

Identifiers

Catalog Number
MFELP4 FDA UDI
Primary DI / UDI-DI
00810113683485 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 electrode, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Transcutaneous electrical stimulation electrode, reusable

ManaFlexx 2 Electrodes - 4 electrodes by Manamed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Transcutaneous electrical stimulation electrode, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Manamed Llc

Sources (1)

  • FDA UDI 753409a4-058c-4d21-ad7a-7092d4da0552 35 fields · synced Jun 6, 2026