Catalog Number

-

Brand Name

RL-500

Version/Model Number

1HDGM00

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

-

Product Code

BXB

Product Code Name

Exerciser, Powered

Public Device Record Key

6ba0eb1b-fefa-42fc-baba-8af98bc022ea

Public Version Date

March 16, 2021

Public Version Number

1

DI Record Publish Date

March 08, 2021

Package DI Number

18809315679784

Quantity per Package

4

Contains DI Package

08809315679787

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-