FeetMe Monitor FTM-DK

Basic Information

• Brand Name: FeetMe Monitor FTM-DK
• Primary DI: 03760349820048
• Version / Model: PVT2
• Company Name: FEETME
• Labeler DUNS: 265478109
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-11
• Public Version: 1
• Public Version Date: 2022-11-21
• Public Version Status: New
• Public Device Record Key: 5d2b2b7f-7b8f-459e-8f19-bf068b1db261

Device Description

FeetMe Monitor Medical device corresponding to a pair of connected insoles Model FTM-DK and version PVT2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
JFC	System, Pressure Measurement, Intermittent	Physical Medicine	890.1600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61782	Pressure monitoring insole	A battery-powered device intended to be worn against the sole of the foot to sense, measure, and transmit information regarding plantar pressure distribution for the biomechanical analysis of gait. It is typically a synthetic insole with integrated pressure sensors and a wireless transmitter, whereby pressure distribution data is intended to be transmitted to, and analysed with, an off-the-shelf tablet/smartphone/computer containing dedicated software; a battery charger may be included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03760349820086	GS1	Commercial box	1	In Commercial Distribution
Primary	03760349820048	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			EU-36
Device Size Text, specify			EU-35
Device Size Text, specify			EU-37
Device Size Text, specify			EU-38
Device Size Text, specify			EU-39
Device Size Text, specify			EU-40
Device Size Text, specify			EU-41
Device Size Text, specify			EU-42
Device Size Text, specify			EU-43
Device Size Text, specify			EU-44
Device Size Text, specify			EU-45
Device Size Text, specify			EU-46

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -10 – 45 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal