FemiScan

Basic Information

• Brand Name: FemiScan
• Primary DI: 06430035220014
• Version / Model: HTCS-2
• Company Name: Bittium Biosignals Oy
• Labeler DUNS: 369960000
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 7
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: f91f60bc-7a24-4949-89b2-d61d9f32f87f
• Distribution End Date: 2021-12-31

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIR	Perineometer	Obstetrics/Gynecology	884.1425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06430035220014	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K993411	000