21 CFR 882.1020 — Analyzer, Rigidity
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1020
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GZM | Analyzer, Rigidity | 2 | 0 |
Special Controls
GZM — Analyzer, Rigidity
*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.
eCFR
