Catalog Number

-

Brand Name

LUMISCOPE

Version/Model Number

SW-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K002874,K002874

Product Code

GZJ

Product Code Name

Stimulator, Nerve, Transcutaneous, For Pain Relief

Public Device Record Key

b67907c0-bd56-4fb0-9658-5aaffdc615a4

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

August 31, 2016

Package DI Number

M368SW10002

Quantity per Package

24

Contains DI Package

M368SW10001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-