# Ataxiagraph With Interpretive Software
> **Product code: PTB** · Class I — Low Risk (general controls) · Neurology · 21 CFR 882.1030
## Classification
- **FDA Product Code:** PTB
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 882.1030
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** Y
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PTB)
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