MYOLAB II

GUDID 00885859004962

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.

MOTION CONTROL, INC

Biofeedback system

• Primary Device ID: 00885859004962
• NIH Device Record Key: 9e98b82a-2b0d-4296-8be3-6522083c4e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MYOLAB II
• Version Model Number: MC-200
• Company DUNS: 177661386
• Company Name: MOTION CONTROL, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885859004962 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-04