Ataxiagraph
The Ataxiagraph is a neurological diagnostic device used to measure and record body sway and postural stability, providing an objective assessment of ataxia and balance disorders. It is classified as FDA Class 1, subject only to general controls and requiring no premarket notification; the exemption is limited to devices that do not provide an interpretation or clinical implication of the measurement. The product code is GWW, regulated under 21 CFR 882.1030 in the Neurology specialty. No special flags apply to this device.
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Basic Information
- Product Code
- GWW
- Device Class
- FDA class 1
- Regulation Number
- 882.1030
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
Definition
Exemption is limited to devices that do not provide an interpretation or a clinical implication of the measurement.
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.