Catalog Number

PRO-1001

Brand Name

PlayMakar

Version/Model Number

PRO-1001

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

K161453,K161453,K161453

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

7fa839e3-a2be-4486-8975-e7c6fc546027

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

February 22, 2019

Package DI Number

20856675008056

Quantity per Package

4

Contains DI Package

10856675008059

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton