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 CodeDevice NameClassDevicesAttributes
GWYPinwheel15
PVPNeurological Test Kit10
Innolitics

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