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
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
d4867640-bf9b-4231-9459-67f9f54b8db5
Public Version Date
September 24, 2021
Public Version Number
4
DI Record Publish Date
May 17, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |