Catalog Number

501-00158-01

Brand Name

NESS L300 Foot Drop System

Version/Model Number

LG3-5100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2017

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122784

Product Code

IPF

Product Code Name

Stimulator, muscle, powered

Public Device Record Key

1997f382-6f7d-412b-ab0b-5548dfd1ea59

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

February 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-