Icoone 620WC34
GUDID 18057592610321
Icoone, icoone Beauty, icoone h (also referred as icoone) is 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
Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Large-area electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager Freestanding electric massager| Primary Device ID | 18057592610321 |
| NIH Device Record Key | 49c833fd-5afe-489d-b10c-eb552d7fbad4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Icoone |
| Version Model Number | ICOONE; ICOONE BEAUTY; ICOONE H |
| Catalog Number | 620WC34 |
| 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
Device Dimensions
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
| Pressure | 20 KiloPascal |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 30 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 18057592610321 [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 | 2023-12-08 |
| Device Publish Date | 2023-11-30 |
Devices Manufactured by I-TECH INDUSTRIES SRL
| 18057592610246 - icoone Laser Healthcare | 2023-12-08 Icoone h (also referred to as Icoone LASER and icoone-h LASER) is Therapeutic Massager machine attached to pivoting wheels, conn |
| 18057592610253 - icoone Healthcare | 2023-12-08 "Icoone, icoone Beauty, icoone h (also referred as icoone Healthcare) is Therapeutic Massager machine attached to pivoting wheel |
| 18057592610260 - Icoone Medical | 2023-12-08 "Icoone, icoone Beauty, icoone h (also referred as icoone Medical) is Therapeutic Massager machine attached to pivoting wheels, |
| 18057592610277 - Icoone Laser Med | 2023-12-08 Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connecte |
| 18057592610307 - Icoone Laser | 2023-12-08 Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to |
| 18057592610321 - Icoone | 2023-12-08Icoone, icoone Beauty, icoone h (also referred as icoone) is 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. |
| 18057592610321 - Icoone | 2023-12-08 Icoone, icoone Beauty, icoone h (also referred as icoone) is Therapeutic Massager machine attached to pivoting wheels, connected |
| 18057592610369 - Icoone Laser Body | 2023-12-08 Icoone Laser Body (also referred to as Icoone body laser) is Therapeutic Massager machine attached to pivoting wheels, connected |
Trademark Results [Icoone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ICOONE 90739354 not registered Live/Pending |
LOUISIN RESEARCH AND DEVELOPMENT LIMITED 2021-05-27 |
 ICOONE 79285369 not registered Live/Pending |
Iconovo AB 2020-03-23 |
 ICOONE 79045309 3431614 Dead/Cancelled |
LOUISIN RESEARCH AND DEVELOPMENT LIMITED 2007-08-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.