Catalog Number

-

Brand Name

Pain-x-2000

Version/Model Number

Infrabed

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K982546

Product Code

ILY

Product Code Name

Lamp, infrared, therapeutic heating

Public Device Record Key

fa24e081-eaac-459a-a5c5-381376fb4a95

Public Version Date

July 07, 2020

Public Version Number

4

DI Record Publish Date

January 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-