Catalog Number

-

Brand Name

VQ ORTHOCARE

Version/Model Number

55-92000-401

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"

Yes

For Single-Use

Yes

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

K030332

Product Code

NYN

Product Code Name

Stimulator, Electrical, Transcutaneous, For Arthritis

Public Device Record Key

a4e3cb4e-f21c-4d5c-9cb3-24f921af707d

Public Version Date

March 11, 2019

Public Version Number

4

DI Record Publish Date

July 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-