J Sport Plus - J Sport Plus is an EMS (Electrical Neuromuscular - EasyMed Instruments Co., Ltd.

Duns Number:526951168

Device Description: J Sport Plus is an EMS (Electrical Neuromuscular Stimulator), which is indicated for:1. Re

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More Product Details

Catalog Number

-

Brand Name

J Sport Plus

Version/Model Number

J Sport Plus

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)

Yes

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

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

3a3f7dec-5ddd-4c77-82a5-df1b18235521

Public Version Date

February 19, 2021

Public Version Number

8

DI Record Publish Date

December 31, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EASYMED INSTRUMENTS CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 25