MedX Rehab Console System - The MedX Rehab Console System is a therapeutic - MedX Health Corp

Duns Number:202128257

Device Description: The MedX Rehab Console System is a therapeutic Low-Level Laser therapy system used for the The MedX Rehab Console System is a therapeutic Low-Level Laser therapy system used for the treatment of a variety of medical conditions such as pain management, swelling, inflammation, bruising, wound healing 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 the high quality handheld laser therapy device and also two SLD light diode cluster accessories. The MedX SLD Light Cluster accessory offers SLD light therapy for broader treatment applications. This accessory can be strapped to the body for "hands-free" unattended treatment.

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More Product Details

Catalog Number

-

Brand Name

MedX Rehab Console System

Version/Model Number

3116

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)

-

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 Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

e0e8a338-475c-44ab-a838-97b2da9e2fe3

Public Version Date

May 07, 2019

Public Version Number

9

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

30628451918159

Quantity per Package

3

Contains DI Package

00628451918158

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

brown carton box

"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