FemiScan

GUDID 06430035220014

FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by using EMG-signals.

Mega Elektroniikka Oy

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• Primary Device ID: 06430035220014
• NIH Device Record Key: f91f60bc-7a24-4949-89b2-d61d9f32f87f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemiScan
• Version Model Number: HTCS-2
• Company DUNS: 369960000
• Company Name: Mega Elektroniikka Oy
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: mega@megaemg.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com
• Phone: +358175817700
• Email: bbs@bittium.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035220014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993411

FDA Product Code

• HIR: Perineometer

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: 2016-09-22

On-Brand Devices [FemiScan]

• 06430035220021: Electrode for FemiScan HomeTrainer (HTCS) device. For single patient use.
• 06430035220014: FemiScan device is for monitoring and recording muscle activity of the pelvic floor muscles by u