FDA UDI
In Commercial Distribution
🇺🇸 United States
icoone Healthcare
DI: 18057592610253
·
Model: ICOONE; ICOONE BEAUTY; ICOONE H
·
I-TECH INDUSTRIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- icoone Healthcare
- Primary DI
- 18057592610253
- Version / Model
- ICOONE; ICOONE BEAUTY; ICOONE H
- Catalog Number
- 601HC14
- Company Name
- I-TECH INDUSTRIES SRL
- Labeler DUNS
- 440986833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-11-30
- Public Version
- 1
- Public Version Date
- 2023-12-08
- Public Version Status
- New
- Public Device Record Key
- 67d511c6-39f5-4141-bbaf-126d43b0b5e4
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. "
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35538 | Large-area electric massager | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18057592610253 | GS1 |
Customer Contacts
- Phone
- 9149071850
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Pressure | 20 | KiloPascal |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 KiloPascal
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 30 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 75 Percent (%) Relative Humidity