FDA.reportPublic FDA data

MedX Rehab Console System

Primary DI
00628451918103
Brand
MedX Rehab Console System
Company
MedX Health Corp
Model
3110
Device description
The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruise and many other conditions that require therapy. The device has been designed for ease of use by licensed healthcare professionals and/or designated assistants. The MedX MBM1100N Console powers three SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader variety of applications. This Cluster accessories can be strapped to the body for "hands-free" unattended treatment.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032231000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032231000MEDX1100 CONSOLE & MEDX 100T AND DUOLIGHT LASER ACCESSORIES, MEDX 100 PORTABLE LASERMedx Electronics, Inc.2003-10-03ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628451918103Direct MarkingGS10
10628451918124PackageGS11Not in Commercial Distribution
20628451918121PackageGS12In Commercial Distribution
20628451918145PackageGS12In Commercial Distribution
20628451918152PackageGS12In Commercial Distribution
20628451918251PackageGS12In Commercial Distribution
20628451918268PackageGS12In Commercial Distribution
30628451918128PackageGS13In Commercial Distribution
30628451918142PackageGS13In Commercial Distribution
30628451918159PackageGS13In Commercial Distribution
30628451918258PackageGS13In Commercial Distribution
30628451918265PackageGS13In Commercial Distribution
40628451918156PackageGS14Not in Commercial Distribution
50628451918122PackageGS15In Commercial Distribution
50628451918146PackageGS15In Commercial Distribution
50628451918153PackageGS15In Commercial Distribution
50628451918252PackageGS15In Commercial Distribution
50628451918269PackageGS15In Commercial Distribution
00628451918127PrimaryGS10
00628451918141PrimaryGS10
00628451918158PrimaryGS10
00628451918257PrimaryGS10
00628451918264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628451918103006284519181036284519181030628451918103
1062845191812410628451918124
2062845191812120628451918121
2062845191814520628451918145
2062845191815220628451918152
2062845191825120628451918251
2062845191826820628451918268
3062845191812830628451918128
3062845191814230628451918142
3062845191815930628451918159
3062845191825830628451918258
3062845191826530628451918265
4062845191815640628451918156
5062845191812250628451918122
5062845191814650628451918146
5062845191815350628451918153
5062845191825250628451918252
5062845191826950628451918269
00628451918127006284519181276284519181270628451918127
00628451918141006284519181416284519181410628451918141
00628451918158006284519181586284519181580628451918158
00628451918257006284519182576284519182570628451918257
00628451918264006284519182646284519182640628451918264

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 Humidity20 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628451918318MedX Oralase Tethered Laser2002018-10-17
00628451918288MedX Rehab Console1100N2018-10-17
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

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Primary DI, Brand, Company table
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00810140063014RENPHOJoicom CorporationILY2026-05-08
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