AccessGUDID - DEVICE: ManaFlexx 2 (00850998008089)

GUDID

Device Identifier (DI) Information

Brand Name: ManaFlexx 2
Version or Model: MF002-RX
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MF002-RX
Company Name: Manamed, Inc.

Primary DI Number: 00850998008089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 084042331 *Terms of Use

Device Description: The ManaFlexx 2 delivers electric pulse generated to the user’s body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. For Prescription Use: TENS: ManaFlexx2 (MF002-RX) is intended for the following use:- Symptomatic relief and management of chronic, intractable pain- Adjunctive treatment for post-surgical and post-trauma acute pain- Relief of pain associated with arthritis PMS/NMES: ManaFlexx2 (MF002-RX) is intended for the following use:- Temporary relaxation of muscle spasm- Prevention or retardation of disuse atrophy- Muscle re-education- Maintaining or increasing range of motion- Increase of local blood flow in the treatment area- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscle

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:	No
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
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning
NUH	Stimulator, Nerve, Transcutaneous, Over-The-Counter
NYN	Stimulator, Electrical, Transcutaneous, For Arthritis
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief
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: a487a1b3-3e30-4087-a427-100de3fbb22c
Public Version Date: February 21, 2025
Public Version Number: 4
DI Record Publish Date: April 30, 2024