Catalog Number

-

Brand Name

THERMI 250

Version/Model Number

APMD115C

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151296

Product Code

PBX

Product Code Name

Massager, Vacuum, Radio Frequency Induced Heat

Public Device Record Key

47fd4dbb-d410-4f3f-bd1c-9903d5c0b8f5

Public Version Date

November 30, 2020

Public Version Number

5

DI Record Publish Date

September 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-