Duns Number:251050084
Device Description: The Dolphin Neurostim Classic is the latest and most scientifically advanced point stimula The Dolphin Neurostim Classic is the latest and most scientifically advanced point stimulator on the market. Features an easy-to-use point locator and 600% more power than leading our competitors. Dolphin Point stimulation may be applied with either left or right hands or using an extension probe, grounding pads, or ear clips. Other standard accessories include a 9-volt battery, carrying case, and instruction manual.
Catalog Number
-
Brand Name
Dolphin Neurostim
Version/Model Number
Classic
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133789,K023726,K023726,K133789,K133789,K023726
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
a10156fd-ed7b-4272-8092-cc1bb53a555b
Public Version Date
September 24, 2021
Public Version Number
1
DI Record Publish Date
September 16, 2021
Package DI Number
10628176737000
Quantity per Package
1
Contains DI Package
00628176737003
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carrying Case