Duns Number:202128257
Device Description: The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used The MedX Brand Light Therapy home unit is a light therapy system for home use. It is used by the patient to treat a variety of medical conditions such a chronic pain, swelling, inflammation, bruising, wound healing, and much more. The device utilizes an LED light diode cluster that contain a large number of red light diodes. The cluster can be attached to the skin surface with the velcro straps prior to beginning a treatment.
Catalog Number
-
Brand Name
MedX Home Unit - Light Therapy system
Version/Model Number
2031
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
K050022,K050022,K050022,K050022,K050022
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
23bb1b26-6f9c-4883-938d-4635e8050885
Public Version Date
May 07, 2019
Public Version Number
8
DI Record Publish Date
September 24, 2016
Package DI Number
50628451918184
Quantity per Package
5
Contains DI Package
00628451918189
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 |