MedX Rehab Portable Laser - The MedX Rehab Portable Laser cluster-stand - MedX Health Corp

Duns Number:202128257

Device Description: The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Lev The MedX Rehab Portable Laser cluster-stand alone, LCS 450, delivers high-quality Low Level Laser Therapy (LLLT). The battery powered, hand-held device is utilized to treat a variety of conditions such as swelling, bruising, pain management, inflammation and many other conditions. The device utilizes three near infrared laser diodes and one visible blue LED that deliver LLLT therapy. The MedX Portable Laser has a power output of 450 mW, and a wavelength of 808 nm and has been designed for licensed or certified healthcare professionals.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.

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More Product Details

Catalog Number

-

Brand Name

MedX Rehab Portable Laser

Version/Model Number

0455

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

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

643c2ce5-3535-423f-bfd6-6a8bc39315f9

Public Version Date

May 07, 2019

Public Version Number

3

DI Record Publish Date

October 31, 2018

Additional Identifiers

Package DI Number

90628451918397

Quantity per Package

25

Contains DI Package

00628451918394

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