Catalog Number

Art.-Nr. 662.19

Brand Name

Vitalcontrol

Version/Model Number

SEM05 MASSAGE ARMS & LEGS

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

-

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Public Device Record Key

f9b82e44-64c6-4647-b781-c56b5ed2315b

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

April 17, 2017

Package DI Number

10853879007048

Quantity per Package

20

Contains DI Package

00853879007041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack