Catalog Number

-

Brand Name

PURE ENRICHMENT

Version/Model Number

PETNEMHT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K221384,K221384,K221384

Product Code

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Public Device Record Key

2ab9d5d9-0f24-47a3-8cfd-11cfa5e34a07

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Package DI Number

B311PETNEMHT1

Quantity per Package

32

Contains DI Package

B311PETNEMHT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

MASTER CARTON