Pain Remedy - Electronic Muscle Stimulator - Hi-Dow International Incorporated

Duns Number:124034476

Device Description: Electronic Muscle Stimulator

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More Product Details

Catalog Number

-

Brand Name

Pain Remedy

Version/Model Number

C05W

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2021

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)

-

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

NGX

Product Code Name

Stimulator, Muscle, Powered, For Muscle Conditioning

Device Record Status

Public Device Record Key

0883b74b-66f7-44e7-aa42-83ccc9966383

Public Version Date

November 03, 2021

Public Version Number

9

DI Record Publish Date

April 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HI-DOW INTERNATIONAL INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 68