EMYO® EM100-N

GUDID 00852423006455

EMYO®100 is a Single Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation

PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE

Kinesiology/electromyographic sensor set

• Primary Device ID: 00852423006455
• NIH Device Record Key: eaf3369c-e074-4e49-9561-1bb73ce31edc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMYO®
• Version Model Number: EMYO®100
• Catalog Number: EM100-N
• Company DUNS: 625863568
• Company Name: PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852423006455 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-01
• Device Publish Date: 2020-06-23

On-Brand Devices [EMYO®]

• 00852423006455: EMYO®100 is a Single Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
• 00852423006448: EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
• 00852423006486: EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
• 00852423006479: EMYO® 200S is a dual channel EMG System for dysphagia rehabilitation