21 CFR 890.1850 — Stimulator, Muscle, Diagnostic
Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1850
Identification
A diagnostic muscle stimulator is a device used mainly with an electromyograph machine to initiate muscle activity. It is intended for medical purposes, such as to diagnose motor nerve or sensory neuromuscular disorders and neuromuscular function.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ISB | Stimulator, Muscle, Diagnostic | 2 | 5 | 3rd Party |
