Catalog Number

16461

Brand Name

Human Tecar

Version/Model Number

CAP electrode Ø 65 mm

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

K181211

Product Code

PBX

Product Code Name

Massager, Vacuum, Radio Frequency Induced Heat

Public Device Record Key

5afa6934-cad4-471b-bc0d-d9f8937aff24

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-