Caring Mill - Easy Relief TENS Large Replacement Pads - Caring Mill

Duns Number:049283340

Device Description: Easy Relief TENS Large Replacement Pads

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More Product Details

Catalog Number

ACNCMTENSLP

Brand Name

Caring Mill

Version/Model Number

ACNCMTENSLP

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

K171381

Product Code Details

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Device Record Status

Public Device Record Key

fbf3d3d1-1d3c-4e26-a169-d7825db552b7

Public Version Date

March 29, 2021

Public Version Number

1

DI Record Publish Date

March 19, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARING MILL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16