Catalog Number

PD-01MT

Brand Name

PowerDot

Version/Model Number

PD-01MT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2099

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)

-

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

4f7bba9f-25a3-4c65-936b-ef42eb7c813e

Public Version Date

December 18, 2019

Public Version Number

1

DI Record Publish Date

December 10, 2019

Package DI Number

04719872330615

Quantity per Package

8

Contains DI Package

04719872330592

Package Discontinue Date

December 31, 2099

Package Status

In Commercial Distribution

Package Type

box