Catalog Number

AAUL25101702

Brand Name

Mini Speed HP

Version/Model Number

1

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

K160075

Product Code

IMI

Product Code Name

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Public Device Record Key

d5273776-9800-426a-b92e-bd10ac131e55

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-