Duns Number:942011719
Device Description: The Yingdi brand Multi-Purpose Health Device is the most reliable, long lasting and versat The Yingdi brand Multi-Purpose Health Device is the most reliable, long lasting and versatile electro acupuncture stimulator. It is one of the best selling acupuncture devices in the world.
Catalog Number
-
Brand Name
Yingdi Multi Purpose Health Device
Version/Model Number
808-III/G-6N
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BWK
Product Code Name
Stimulator, Electro-Acupuncture
Public Device Record Key
ec7a18ea-4677-4a1a-957d-c8f4fe80232d
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
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. | 6 |
| U | Unclassified | 3 |