IKO · Hammer, Reflex, Powered
Physical Medicine · 21 CFR 890.1450 · Class 2
Overview
| Product Code | IKO |
|---|---|
| Device Name | Hammer, Reflex, Powered |
| Regulation | 21 CFR 890.1450 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
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.
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 § 890.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904113 | OPERATIVE RECORDING CAMERA | Medical Dynamics, Inc. | Oct 30, 1990 | SESE |
Top Applicants
- Medical Dynamics, Inc. — 1 clearance
