GZM · Analyzer, Rigidity
Neurology · 21 CFR 882.1020 · Class 2
Overview
| Product Code | GZM |
|---|---|
| Device Name | Analyzer, Rigidity |
| Regulation | 21 CFR 882.1020 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A rigidity analyzer is a device for quantifying the extent of the rigidity of a patient's limb to determine the effectiveness of drugs or other treatments.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Cleared Devices (0)
No cleared devices on record.
