Icoone 695WC34

GUDID 08057592610676

icoone-M is a therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand.

I-TECH INDUSTRIES SRL

Freestanding electric massager

• Primary Device ID: 08057592610676
• NIH Device Record Key: 876ff8cd-8212-4fce-a27b-667b36a49a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Icoone
• Version Model Number: icoone-M
• Catalog Number: 695WC34
• Company DUNS: 440986833
• Company Name: I-TECH INDUSTRIES SRL
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com
• Phone: 9149071850
• Email: stan@skinsciencesolutions.com

Device Dimensions

• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar
• Pressure: -700 millibar

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057592610676 [Primary]

FDA Product Code

• ISA: Massager, Therapeutic, Electric

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: 2026-02-27
• Device Publish Date: 2026-02-19

On-Brand Devices [Icoone]

• 18057592610321: Icoone, icoone Beauty, icoone h (also referred as icoone) is Therapeutic Massager machine attach
• 08057592610676: icoone-M is a therapeutic Massager machine attached to pivoting wheels, connected to a rolling s