SLD Light cluster - The MedX SLD Light diode Cluster, with an output - MedX Health Corp

Duns Number:202128257

Device Description: The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the The MedX SLD Light diode Cluster, with an output power of 500mW, is used together with the Richmar console to treat a variety of medical conditions.It is a light therapy device that can effectively treat conditions like pain, swelling, bruising, inflammation, wound healing and several other conditions. The device utilizes super-luminous diode technology in both infrared and visible red diodes which produce photons of energy and trigger physiological changes in tissue. With the included velcro flexstrap, the SLD cluster can be strapped to the body and be used hands-free or it can be hand-held over the area to be treated.This particular model is private-labeled for Richmar, a medical device company based in Chattanooga, TN, USA which makes medical devices used in physical therapy.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

SLD Light cluster

Version/Model Number

MCT 507

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

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

-

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

96f11e3e-63cb-4285-b260-298965199767

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

November 06, 2018

Additional Identifiers

Package DI Number

60628451918419

Quantity per Package

6

Contains DI Package

00628451918417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDX HEALTH CORP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3