AccessGUDID - DEVICE: ManaFlexx (00850998008034)

GUDID

Device Identifier (DI) Information

Brand Name: ManaFlexx
Version or Model: MF0001-RX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00850998008034
Company Name: Manamed, Inc.

Primary DI Number: 00850998008034
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: ManaFlexx is the only NMES device designed for ease of use by eliminating wires or standalone electrodes. 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. Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, Muscle, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 453a1c4c-37a7-4f42-8073-8777241188da
Public Version Date: July 11, 2024
Public Version Number: 9
DI Record Publish Date: October 02, 2017