Duns Number:828331616
Device Description: The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Esti The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Estim probe, Interferential Currentin bipolar or quadripolar modes, or Monochromatic Infrared Therapy to reduce pain and increase circulation.Flexible neoprene pads deliver heat and Infrared therapy through multiple clusters of infrared and red visible superluminous diodes (SLD).The Neuroprobe® 500 Pro’s optional probe with fully adjustable parameters provides a wide variety of uses for painmanagement with trigger point stimulation for pain control.The Neuroprobe® 500 Pro provides a nerve block mode through treatment pads with high output capable of sensorynerve block, or through the optional probe to produce local trigger point anesthesia.
Catalog Number
-
Brand Name
Neuroprobe 500 Pro
Version/Model Number
140500B
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
K831147,K831147
Product Code
GZJ
Product Code Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Public Device Record Key
aceb953d-1d89-4577-9e57-25e86ed07747
Public Version Date
September 20, 2021
Public Version Number
4
DI Record Publish Date
August 16, 2016
Package DI Number
10858703006051
Quantity per Package
4
Contains DI Package
00858703006054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
ship carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |