PMRU-S KIT

GUDID B25972000

Electrical diagnostic functional assessment, combining range of motion, functional capacity, and electromyography testing

EMERGE DIAGNOSTICS LLC

Electromyography telemetric monitoring system

• Primary Device ID: B25972000
• NIH Device Record Key: dc44d308-3794-4415-b2b1-6abcbdb4db13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PMRU-S KIT
• Version Model Number: 7200
• Company DUNS: 078787134
• Company Name: EMERGE DIAGNOSTICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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
HIBCC	B25972000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123902

FDA Product Code

• OAL: Exercise Equipment, Powered, Emg-Triggered

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-26