Catalog Number

PD-01

Brand Name

PowerDot

Version/Model Number

PD-01B

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

eafcaa2f-80f6-4bad-9c04-a49e796a5558

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Package DI Number

14719872330353

Quantity per Package

2

Contains DI Package

04719872330318

Package Discontinue Date

December 31, 2099

Package Status

In Commercial Distribution

Package Type

Color Box