TENS 210 - Two-channel battery-operated TENS unit - METTLER ELECTRONICS CORP.

Duns Number:008513913

Device Description: Two-channel battery-operated TENS unit

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More Product Details

Catalog Number

ME 210

Brand Name

TENS 210

Version/Model Number

ME 210

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"

Yes

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

K002874

Product Code Details

Product Code

GZJ

Product Code Name

STIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF

Device Record Status

Public Device Record Key

6272d91e-4988-4009-bb35-ec131d3d07c2

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"METTLER ELECTRONICS CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 57