21 CFR 882.1750 — Pinwheel
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1750
Identification
A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GWY | Pinwheel | 1 | 5 | |
| PVP | Neurological Test Kit | 1 | 0 |