Catalog Number

-

Brand Name

PainAway Pro

Version/Model Number

RTLAGF-910

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

-

Product Code

NGX

Product Code Name

STIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING

Public Device Record Key

4d4a866a-a66e-460f-8d48-539273c7f36b

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

July 01, 2016

Package DI Number

10822383549405

Quantity per Package

36

Contains DI Package

00822383549408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-