FDA UDI
In Commercial Distribution
🇺🇸 United States
Inceler Medikal
DI: 08680050920019
·
Model: Modus F
·
INCELER MEDIKAL SAGLIK HIZMETLERI SANAYI TICARET LIMITED SIRKETI
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Inceler Medikal
- Primary DI
- 08680050920019
- Version / Model
- Modus F
- Catalog Number
- IMED-850
- Company Name
- INCELER MEDIKAL SAGLIK HIZMETLERI SANAYI TICARET LIMITED SIRKETI
- Labeler DUNS
- 519905912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-08
- Public Version
- 1
- Public Version Date
- 2024-02-16
- Public Version Status
- New
- Public Device Record Key
- c24fae6b-916b-48b1-b77d-f047c17e8e9a
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| 47032 | Pneumatic orthopaedic extracorporeal shock wave therapy system | An assembly of devices designed to provide pneumatic orthopaedic extracorporeal shock wave therapy (OEST) to treat musculoskeletal disorders. It typically consists of a control unit that produces pneumatically-generated shock waves at selected impulse frequencies, and a hand-held surface applicator used to apply the energy to the site of pain. It is commonly used to treat disorders such as tendinopathies (e.g., rotator cuff, patellar, Achilles), soft tissue pain near bones, plantar fasciitis (heel pain), epicondylopathy (tennis elbow), shin splints, and muscle-related pain syndromes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08680050920019 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 80 Percent (%) Relative Humidity