Duns Number:529966489
Device Description: Needle Stimulator is combined with modern micro computer high-new technique, traditional C
Catalog Number
-
Brand Name
Jiajian
Version/Model Number
CMNS2-1
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"
-
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
K130768,K130768
Product Code
BWK
Product Code Name
Stimulator, Electro-Acupuncture
Public Device Record Key
0b53461b-52af-4a3a-aa4b-13bca9d8bc34
Public Version Date
October 23, 2019
Public Version Number
2
DI Record Publish Date
November 26, 2018
Package DI Number
20810011252503
Quantity per Package
20
Contains DI Package
00810011252509
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 123 |
U | Unclassified | 2 |