Identity
- Trade Name
- Icoone Medical FDA UDI
- Generic Name
- Freestanding electric massager FDA UDI
- Device Name
- "Icoone, icoone Beauty, icoone h (also referred as icoone Medical) 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. " FDA UDI
- Model / Reference
- ICOONE; ICOONE BEAUTY; ICOONE H FDA UDI
- Description
- "Icoone, icoone Beauty, icoone h (also referred as icoone Medical) 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. " FDA UDI
Identifiers
- Catalog Number
- 660HC14 FDA UDI
- Primary DI / UDI-DI
- 18057592610260 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Freestanding electric massager FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Pressure — 20 KiloPascal FDA UDI
Category: Freestanding electric massager
Icoone Medical by I-Tech Industries Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- I-Tech Industries Srl
Sources (1)
- FDA UDI 86d6e28d-ff31-4f81-a11b-8a8477ab328b 37 fields · synced Jun 6, 2026