MedX Rehab Console

Primary DI
00628451918288
Brand
MedX Rehab Console
Company
MedX Health Corp
Model
1100N
Device description
The MedX Rehab Console 1100N controls and powers the MedX tethered laser medical device accessories like the Multi-cluster, tethered MCT1001, Laser cluster, tethered LCT450 and Laser probe, tethered LPT 200. It is the main reference for identification and traceability, and part of the kit for MedX Health Item numbers #3110, #3114, #3116, #3120, and #3122. This product is registered for the purpose of having a UDI for direct marking and primary packaging when shipped as a particular item and not as a kit.
Published
2018-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00628451918103Direct MarkingGS10
00628451918288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451918103006284519181036284519181030628451918103
00628451918288006284519182886284519182880628451918288

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), improving 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 internal (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated by a healthcare professional exclusively in a clinical setting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity29 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Temperature-4 Degrees Fahrenheit149 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 905 670 4428tobillo@medxhealth.com

Regulatory Flags#

DUNS number
202128257
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628451918318MedX Oralase Tethered Laser2002018-10-17
00628451918127MedX Rehab Console System31102016-09-24
00628451918141MedX Rehab Console System31142016-09-24
00628451918158MedX Rehab Console System31162016-09-24
00628451918202MedX Oralase Portable Laser09102016-09-24
00628451918219MedX Acupuncture Portable Laser 09122016-09-24
00628451918233MedX Rehab Portable Laser09152016-09-24
00628451918257MedX Oralase Console System31202017-12-22
00628451918264MedX Oralase System31222017-12-27
00628451918325MedX Home Console20302018-10-17
00628451918349MedX Oralase Portable LaserLPS2002018-10-18
00628451918394MedX Rehab Portable Laser04552018-10-31
00628451918189MedX Home Unit - Light Therapy system20312016-09-24
00628451918295MedX SLD Light Cluster10012016-09-24
00628451918301MedX Rehab Tethered Laser4502016-09-24
00628451918332MedX SLD Light ClusterMCT10002016-09-24
00628451918356MedX Rehab Portable Laser LCS4502018-10-18
00628451918417SLD Light clusterMCT 5072018-11-06
00628451918226MedX Rehab Portable Laser09152016-09-24
00628451918103MedX Rehab Console System31102016-09-24

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