Inceler Medikal

Primary DI
08680050920460
Brand
Inceler Medikal
Company
INCELER MEDIKAL SAGLIK HIZMETLERI SANAYI TICARET LIMITED SIRKETI
Model
Modus F
Catalog number
IMED-850-2
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.
Published
2024-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08680050920460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08680050920460086800509204608680050920460

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic orthopaedic extracorporeal shock wave therapy systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
519905912
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
08680050920019Inceler MedikalModus FIMED-8502024-03-20

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