Duns Number:002065670
Device Description: Nerve Stimulator, Peripheral, DEMO w/Ball Electrodes, 9v Battery, Lead Set (Alligator), IF Nerve Stimulator, Peripheral, DEMO w/Ball Electrodes, 9v Battery, Lead Set (Alligator), IFU and Zip Case (RED)
Catalog Number
00-100-PLUS-DEMO
Brand Name
AincA®
Version/Model Number
00-100-PLUS-DEMO
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K811614
Product Code
BXN
Product Code Name
STIMULATOR, NERVE, BATTERY-POWERED
Public Device Record Key
09034b3d-e2a7-4a3c-81a8-8992f520fd96
Public Version Date
May 04, 2021
Public Version Number
2
DI Record Publish Date
March 31, 2021
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 561 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 135 |