Duns Number:600469191
Device Description: The Vibratory Sensory Analyzer VSA-3000 is a computerized device for the quantitative asse The Vibratory Sensory Analyzer VSA-3000 is a computerized device for the quantitative assessment of large nerve fiber dysfunctions, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration.The Device includes: main unit, at least one probe and accessories.
Catalog Number
MO 00003
Brand Name
VSA-3000 Vibratory Sensory Analazer
Version/Model Number
VSA-3000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IRO
Product Code Name
Vibrator, Therapeutic
Public Device Record Key
c633a197-fd9c-425a-8a98-496f4ed5ed30
Public Version Date
June 26, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
07290103039509
Quantity per Package
1
Contains DI Package
07290103039004
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |