Catalog Number

-

Brand Name

TheraTouch

Version/Model Number

DQ8222

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

K120217,K120217

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

64205850-4174-4f05-bf79-eec2a542f105

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

April 27, 2020

Package DI Number

80092237622090

Quantity per Package

2

Contains DI Package

00092237622094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton