Duns Number:529966489
Device Description: An electronic probe used to precisely locate an acupuncture point on a patient's body.It i An electronic probe used to precisely locate an acupuncture point on a patient's body.It is used in complemently medicine therapy either independently or with a device intented to apply stilmuli to acupuncture site (e.g., an electrical stimulator). It may include visual or audio singals to indicate the acupuncture point. This is a reusable device.
Catalog Number
-
Brand Name
Jiajian
Version/Model Number
pointoselect
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
K123958,K123958
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
201310c0-1214-40f2-87f0-97de08061691
Public Version Date
October 22, 2019
Public Version Number
1
DI Record Publish Date
October 14, 2019
Package DI Number
16972011713501
Quantity per Package
20
Contains DI Package
06972011713504
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |