AccessGUDID - DEVICE: E-LINK Myo-EX GX5 Wireless EMG Sensor (05060481690157)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINK Myo-EX GX5 Wireless EMG Sensor
Version or Model: GX5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMETRICS LIMITED

Primary DI Number: 05060481690157
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 519969810 *Terms of Use

Device Description: Highly sensitive Myo-EX sensors use surface EMG for inspiring exercise, beginning from when there is the tiniest flicker of voluntary muscle activity, with or without visible joint movement. GX5 sensor with integral electrodes is applied to the skin with die-cut medical grade hypoallergenic tape. This product is independently tested and certified to BS EN 60601-1:2006 + A1:2013

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?
63313	Kinesiology/electromyographic sensor set	A collection of patient-worn devices consisting of both an electromyographic sensor and motion-based sensor intended to be used in a clinical setting as part of a system (e.g., virtual-display rehabilitation system, biomechanical analysis system) to provide non-gravity-compensating analysis, biofeedback, and/or interactive rehabilitation of neuromuscular/musculoskeletal conditions. It is typically intended to be used with a computer, interface devices, and software (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback
ISD	Exerciser, Measuring

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b61ef2c1-96cb-47d0-b67e-694d4c203489
Public Version Date: September 10, 2018
Public Version Number: 1
DI Record Publish Date: August 10, 2018