Famidoc - The stimulator may be used for the - Famidoc Technology Co.,Ltd.

Duns Number:421343701

Device Description: The stimulator may be used for the following:Symptomatic relief of chronic intractable pa The stimulator may be used for the following:Symptomatic relief of chronic intractable pain,Post traumatic pain,post surgical pain,Relaxation of muscle spasm, Increase blood flow circulation,Prevention or retardation of disuse atrophy, Muscle re-education, Maintaining or increasing range of motion,Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

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More Product Details

Catalog Number

-

Brand Name

Famidoc

Version/Model Number

FDES101

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

K113010,K113010

Product Code Details

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Device Record Status

Public Device Record Key

b7b6b133-2c79-4e0d-81e4-f4a29ebb5657

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

October 17, 2016

Additional Identifiers

Package DI Number

16970389634015

Quantity per Package

36

Contains DI Package

06970389634018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FAMIDOC TECHNOLOGY CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 43