21 CFR 890.1450 — Hammer, Reflex, Powered
Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1450
Identification
A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes.
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 § 890.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IKO | Hammer, Reflex, Powered | 2 | 1 |
Special Controls
IKO — Hammer, Reflex, Powered
*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 § 890.9.
eCFR
