CHELT F EB 60

Primary DI
08051499971007
Brand
CHELT F EB 60
Company
MECTRONIC MEDICALE SRL
Model
1CTFEB60
Device description
CHELT is a medical device for laser and cryo therapy, designed to provide topical heating for the purpose of elevating tissues temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporary increase local blood circulation. It is an accurate tool which is able to meet every therapeutic requirement. CHELT features a wide range of settings for power and wavelength.
Published
2024-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08051499971007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08051499971007080514999710078051499971007

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal/physical therapy laser, professionalAn electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
429098838
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

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08051499971342iLux LF Y151LFY152024-10-10
08051499971359iLux LF HPS D301LFHD302024-10-10
08051499971366iLux LF HPS V101LFHV102024-10-10
08051499971373iLux LF HPS Y101LFHY102024-10-10
08051499971403iLux LF HPS R21LFHR22024-10-10
08051499971410iLux LF HPS V151LFHV152024-10-10
08051499971427iLux LF HPS V201LFHV202024-10-10
08051499971434iLux LF HPS D151LFHD152024-10-10
08051499971441iLux LF HPS D201LFHD202024-10-10
08051499971458iLux LF HPS V301LFHV302024-10-10
08051499971489iLux LF HPS T301LFHT302024-10-10
08051499971502iLux LF HPS T201LFHT202024-10-10

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