MiBo Heating Pad Mask - Thermal heating pad with Far Infrared technology - PAIN POINT MEDICAL SYSTEMS INC.

Duns Number:084045250

Device Description: Thermal heating pad with Far Infrared technology to help heating and blood circulation aro Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.

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More Product Details

Catalog Number

-

Brand Name

MiBo Heating Pad Mask

Version/Model Number

3936275

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

February 21, 2026

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Device Record Status

Public Device Record Key

777d5f6c-9983-4708-b069-5487821ba2bf

Public Version Date

May 06, 2021

Public Version Number

1

DI Record Publish Date

April 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PAIN POINT MEDICAL SYSTEMS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1