DEKA PHYSIQ - The PHYSIQ is a system provided with 4 IR LED to - EL.EN. SPA

Duns Number:436887608

Device Description: The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose o The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscles.A LED mounted on top of each handpiece is lighted when the handpiece is emitting.

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More Product Details

Catalog Number

M120F1

Brand Name

DEKA PHYSIQ

Version/Model Number

M120F1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

ILY

Product Code Name

Lamp, Infrared, Therapeutic Heating

Device Record Status

Public Device Record Key

3fb5fd53-0f94-4a43-95e6-7873b53d4118

Public Version Date

January 23, 2020

Public Version Number

1

DI Record Publish Date

January 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EL.EN. SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46