21 CFR 882.1030 — Ataxiagraph
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1030
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWW | Ataxiagraph | 1 | 0 | |
| PTB | Ataxiagraph With Interpretive Software | 1 | 0 | SaMD, 3rd Party |
