FDA.reportPublic FDA data

icoone Healthcare

Primary DI
18057592610253
Brand
icoone Healthcare
Company
I-TECH INDUSTRIES SRL
Model
ICOONE; ICOONE BEAUTY; ICOONE H
Catalog number
601HC14
Device description
"""Icoone, icoone Beauty, icoone h (also referred as icoone Healthcare) 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. """
Published
2023-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18057592610253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1805759261025318057592610253

GMDN Terms#

Term, Definition table
TermDefinition
Large-area electric massagerAn electrically-powered device designed to provide therapeutic massage to a larger area than hand-held massaging devices. It may utilize vibrating belts or other interchangeable mechanisms that are applied to the body to mechanically stimulate the musculature or provide other physiotherapy treatment. This device is intended for use in healthcare facilities and is not applicable to home therapies.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Pressure20KiloPascal

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure30 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 KiloPascal30 KiloPascal

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9149071850stan@skinsciencesolutions.com

Regulatory Flags#

DUNS number
440986833
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057592610676Icooneicoone-M695WC342026-02-19
18057592610246icoone Laser HealthcareICOONE h (also referred to as ICOONE LASER and ICO601EC142023-11-30
18057592610260Icoone MedicalICOONE; ICOONE BEAUTY; ICOONE H660HC142023-11-30
18057592610277Icoone Laser MedICOONE Laser Med (also called ICOONE MEDICAL LASER650EC242023-11-30
18057592610307Icoone LaserIcoone Laser (also referred to as Icoone beauty la610BC042023-11-30
18057592610321IcooneICOONE; ICOONE BEAUTY; ICOONE H620WC342023-11-30
18057592610369Icoone Laser BodyIcoone laser body (also referred to as Icoone body611BC142023-11-30

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Primary DI, Brand, Company table
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00045915831493Human TouchHuman Touch, LLCISA2026-01-12
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