Footswitch

Basic Information

• Brand Name: Footswitch
• Primary DI: EMTDE100201USMP1
• Version / Model: E100201USMP
• Catalog Number: E100201USMP
• Company Name: MT.DERM GmbH
• Labeler DUNS: 329216357
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-23
• Public Version: 7
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: 16658634-77d4-4aba-b540-487520eb1496
• Distribution End Date: 2022-01-01

Device Description

Box of Footswitch. The Footswitch is an accessory of Exceed AD61USMP.

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
QAI	Powered Microneedle Device	General, Plastic Surgery	878.4430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61216	Cosmetic micro-needling electronic handpiece, professional	A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EMTDE100201USMP1	HIBCC

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 54 – 107 KiloPascal
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 60 – 107 KiloPascal