Icy Hot SmartRelief - Over-The-Counter (OTC) Transcutaneous Electrical - CHATTEM, INC.

Duns Number:003336013

Device Description: Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Should Over-The-Counter (OTC) Transcutaneous Electrical Nerve Stimulator (TENS) - Knee and Shoulder

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More Product Details

Catalog Number

-

Brand Name

Icy Hot SmartRelief

Version/Model Number

SmartRelief 1.0 - Knee/Shoulder Kit

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

Yes

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

K131159

Product Code Details

Product Code

NUH

Product Code Name

Stimulator, Nerve, Transcutaneous, Over-The-Counter

Device Record Status

Public Device Record Key

35b83a9a-3a5a-47fb-99d1-09489f5fa5d3

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

August 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CHATTEM, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5