Catalog Number

29673

Brand Name

Erigo

Version/Model Number

Pro

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132416

Product Code

BXB

Product Code Name

Exerciser, Powered

Public Device Record Key

d99a1c9e-d263-4887-9adf-f8139f9bf51c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-