Duns Number:202128257
Device Description: The MedX Rehab Laser Console System is a Low-Level Laser therapy system used for the treat 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.
Catalog Number
-
Brand Name
MedX Rehab Console System
Version/Model Number
3110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K032231,K032231,K032231,K032231,K032231,K032231
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
719e1e63-a6eb-44d8-9fff-da7ffc8ccf7e
Public Version Date
May 07, 2019
Public Version Number
9
DI Record Publish Date
September 24, 2016
Package DI Number
50628451918122
Quantity per Package
5
Contains DI Package
00628451918127
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping carton box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |