Duns Number:202128257
Device Description: The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for M The MedX Health portable-tethered laser medical device or LPT201 is part of the kit for MedX Health item numbers #3120 and #3122. It is controlled and powered by MedX Rehab Console MBM1100N. This product is registered for the purpose showing its UDI for direct marking and primary packaging when shipped as a particular item and not as part of a kit.
Catalog Number
-
Brand Name
MedX Laser Portable, tethered
Version/Model Number
201
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
K082707,K082707
Product Code
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
cea585b5-785a-4428-a287-b71f51b7115f
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
October 17, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |