Catalog Number

-

Brand Name

Theragun

Version/Model Number

Theragun Elite

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

-

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

ISA

Product Code Name

Massager, Therapeutic, Electric

Public Device Record Key

35a2f829-5f50-4b86-b28e-1866d6a217f9

Public Version Date

October 07, 2021

Public Version Number

1

DI Record Publish Date

September 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-