Duns Number:663211978
Device Description: Pointer Excel II is the latest and most advanced user friendly stimulator. Features a buil Pointer Excel II is the latest and most advanced user friendly stimulator. Features a built-in, 0.35" x 1.0" LCD digital meter which displays both frequency and location. Unit features two grounding plates on the unit (allowing use with either left or right hands) as well as a hand probe with grounding pole and attached wire. Two probe tips are included with unit: ear 2 mm (0.08") and body 4 mm (0.16"). Other standard accessories include 9 volt battery, carrying case, and instructions.
Catalog Number
ED3988
Brand Name
Pointer Excel II
Version/Model Number
ED3988
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060517,K060517
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
029d0ad0-aff2-46df-94db-78d4622119f6
Public Version Date
October 23, 2019
Public Version Number
4
DI Record Publish Date
August 04, 2016
Package DI Number
34897076720058
Quantity per Package
30
Contains DI Package
14897076720054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 1 |