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Inceler Medikal
FDA UDIClass I (US FDA UDI)
by İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi
Identity
- Trade Name
- Inceler Medikal FDA UDI
- Generic Name
- Pneumatic orthopaedic extracorporeal shock wave therapy system FDA UDI
- Device Name
- The Modus-F works by focusing on the relevant area. The working principle of the system is electrohydraulic. In the focused model, Modus devices are used in various conditions and fields such as orthopedics. The Modus-F System is a non-interventional treatment modality based on the transmission of focused sound waves generated outside the body to the selected anatomical region by means of a liquid-filled silicone applicator head. This method accelerates the blood flow in the relevant region, enabling the body’s own healing mechanisms to be activated. The easy-to-use structure of the Modus Pulse Therapy System improves operational efficiency. The system complies with European and North American norms for medical devices. FDA UDI
- Model / Reference
- Modus F FDA UDI
- Description
- The Modus-F works by focusing on the relevant area. The working principle of the system is electrohydraulic. In the focused model, Modus devices are used in various conditions and fields such as orthopedics. The Modus-F System is a non-interventional treatment modality based on the transmission of focused sound waves generated outside the body to the selected anatomical region by means of a liquid-filled silicone applicator head. This method accelerates the blood flow in the relevant region, enabling the body’s own healing mechanisms to be activated. The easy-to-use structure of the Modus Pulse Therapy System improves operational efficiency. The system complies with European and North American norms for medical devices. FDA UDI
Identifiers
- Catalog Number
- IMED-850-2 FDA UDI
- Primary DI / UDI-DI
- 08680050920460 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Pneumatic orthopaedic extracorporeal shock wave therapy system 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
No
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
Category: Pneumatic orthopaedic extracorporeal shock wave therapy system
Inceler Medikal by İnceler Medikal Sağlık Hizmetleri Sanayi Ticaret Limited Şirketi — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Radial Pressure Pulse Therapy Device — Guangzhou Pinzhi Medical Technology Co., LTD · Class I
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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
Sources (1)
- FDA UDI 075d1c49-b298-4b94-99bf-ed1572aed528 35 fields · synced Aug 1, 2026