Duns Number:526876993
Device Description: Electronic Pulse Massager - Massager Unit used with pads sold as a single unit per sale.
Catalog Number
-
Brand Name
SHENZHEN JINGKEHUI ELECTRONIC
Version/Model Number
PL-009
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NUH
Product Code Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Public Device Record Key
c21f4f87-9eae-4a9d-8396-7e4a9a206ecf
Public Version Date
August 20, 2020
Public Version Number
5
DI Record Publish Date
March 09, 2017
Package DI Number
10867587000307
Quantity per Package
20
Contains DI Package
00867587000300
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton