Catalog Number

-

Brand Name

TrueStim

Version/Model Number

HD-08A(TSG-A1)

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202337

Product Code

ILX

Product Code Name

Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

Public Device Record Key

b91282c6-b01a-4c8c-b34e-47d07cc803b8

Public Version Date

November 03, 2021

Public Version Number

2

DI Record Publish Date

December 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-