AccessGUDID - DEVICE: MYOLAB II (00885859004962)

GUDID

Device Identifier (DI) Information

Brand Name: MYOLAB II
Version or Model: MC-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MOTION CONTROL, INC

Primary DI Number: 00885859004962
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 177661386 *Terms of Use

Device Description: The Myolab II was specifically designed for use in fitting and troubleshooting the Utah Arm and ProPlus myoelectric prostheses. It can be used to locate muscle activity down to 0.2 microvolts in the remnant limb. The adjustable gain feature allows the device to test and train muscle EMG for any single or dual-channel myoelectric control system.

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?
10396	Biofeedback system	An assembly of devices intended to provide visual and/or auditory signals corresponding to the status of one or more of a patient's physiological functions, e.g., brain wave activity, muscle activity, blood pressure, skin temperature, balance, so that the patient can develop some degree of conscious control over a usually involuntarily function. This system will detect changes in the physiological functions that are outside of the normal awareness, amplify these signals, and provide this as feedback to the patient. It is used in, e.g., tension headache control, muscle relaxation, rehabilitation/training, behavioural research.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9e98b82a-2b0d-4296-8be3-6522083c4e60
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 04, 2016