21 CFR 890.1225 — Chronaximeter
Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1225
Identification
A chronaximeter is a device intended for medical purposes to measure neuromuscular excitability by means of a strength-duration curve that provides a basis for diagnosis and prognosis of neurological dysfunction.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IKP | Chronaximeter | 2 | 0 | 3rd Party |