AccessGUDID - DEVICE: NES miHealth Refurbished Device (05060534830011)

GUDID

Device Identifier (DI) Information

Brand Name: NES miHealth Refurbished Device
Version or Model: NESMH01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NES HEALTH LIMITED

Primary DI Number: 05060534830011
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 423365332 *Terms of Use

Device Description: The NES mihealth is a Hand held electronic bio-feedback device, which is battery powered.

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):	No
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
HCC	Device, Biofeedback

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Height: 17.2 Centimeter
Weight: 164 Gram
Depth: 1.7 Centimeter
Width: 6.4 Centimeter

Device Record Status

Public Device Record Key: 8f77066f-8077-4149-987a-aef75290cac1
Public Version Date: February 05, 2025
Public Version Number: 7
DI Record Publish Date: November 16, 2018