Catalog Number

-

Brand Name

PainAway Pro

Version/Model Number

RTLAGF-940

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

f0a37258-c017-46c1-86ac-4befb1af5290

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

July 01, 2016

Package DI Number

50822383549465

Quantity per Package

8

Contains DI Package

10822383549467

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-