PTB · Ataxiagraph With Interpretive Software
Neurology · 21 CFR 882.1030 · Class 1
Overview
| Product Code | PTB |
|---|---|
| Device Name | Ataxiagraph With Interpretive Software |
| Regulation | 21 CFR 882.1030 |
| Device Class | Class 1 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An ataxiagraph is a 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.
Classification Rationale
Class I (general controls). Except when the device is intended to provide an interpretation or a clinical implication of the measurement, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
