Catalog Number

AT7

Brand Name

INDIBA ACTIV - AT7

Version/Model Number

ACT0407USA

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)

Yes

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

K161458

Product Code

PBX

Product Code Name

Massager, vacuum, radio frequency induced heat

Public Device Record Key

13814fcd-bd36-4c28-83c7-aafdfe0abe88

Public Version Date

April 14, 2021

Public Version Number

1

DI Record Publish Date

April 06, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-