FDA product code GWW: Ataxiagraph
GWW is the FDA product code for ataxiagraph. It is a Class I device, regulated under 21 CFR 882.1030 and reviewed by the Neurology panel. Devices under GWW reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Exemption is limited to devices that do not provide an interpretation or a clinical implication of the measurement.
Classification
| Field | Value |
|---|---|
| Device name | Ataxiagraph |
| Device class | Class I |
| Regulation | 21 CFR 882.1030 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Recalls for GWW devices
openFDA lists no recalls for product code GWW.
Frequently asked questions
What is FDA product code GWW?
GWW is the FDA product code for ataxiagraph. It is a Class I device, regulated under 21 CFR 882.1030 and reviewed by the Neurology panel.
What device class is GWW?
Class I, regulation 21 CFR 882.1030. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code GWW
- Run a recall and safety report across every GWW manufacturer
- Watch product code GWW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times