FDA product code PTB: Ataxiagraph With Interpretive Software
PTB is the FDA product code for ataxiagraph with interpretive software. It is a Class I device, regulated under 21 CFR 882.1030 and reviewed by the Neurology panel. Devices under PTB reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
Device used to determine the extent of ataxia (failure of muscular coordination) by measuring the amount of swaying of the body when the patient is standing erect and with eyes closed and provides interpretation or clinical implication of the measurement.
Classification
| Field | Value |
|---|---|
| Device name | Ataxiagraph With Interpretive Software |
| Device class | Class I |
| Regulation | 21 CFR 882.1030 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Recalls for PTB devices
openFDA lists no recalls for product code PTB.
Frequently asked questions
What is FDA product code PTB?
PTB is the FDA product code for ataxiagraph with interpretive software. It is a Class I device, regulated under 21 CFR 882.1030 and reviewed by the Neurology panel.
What device class is PTB?
Class I, regulation 21 CFR 882.1030. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PTB
- Run a recall and safety report across every PTB manufacturer
- Watch product code PTB 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.
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