IKD · Cable, Electrode
Physical Medicine · 21 CFR 890.1175 · Class 2
Overview
| Product Code | IKD |
|---|---|
| Device Name | Cable, Electrode |
| Regulation | 21 CFR 890.1175 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
Identification
An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
Classification Rationale
Class II (special controls). The special controls consist of:(1) The performance standard under part 898 of this chapter, and (2) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 890.9.
Special Controls
*Classification.* Class II (special controls). The special controls consist of:(1) The performance standard under part 898 of this chapter, and (2) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 890.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | Oscor, Inc. | Jun 7, 2007 | SESE |
| K992372 | THE LEADAWAY | Therapy Equipment, Inc. | Oct 13, 1999 | SESE |
| K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | Physiometrix, Inc. | Dec 23, 1993 | SESE |
| K873361 | LIFE-SPAN CABLE | Chemfet Corp. | Nov 9, 1987 | SESE |
| K834583 | CLEAR LEADS-RADIOTRANSPARENT WIRES | Quinton, Inc. | Jan 30, 1984 | SESE |
| K800934 | R2 ESU CABLE-ADAPTER MODELS 160,161 | R2 Corp. | May 20, 1980 | SESE |
Top Applicants
- Chemfet Corp. — 1 clearance
- Oscor, Inc. — 1 clearance
- Physiometrix, Inc. — 1 clearance
- Quinton, Inc. — 1 clearance
- R2 Corp. — 1 clearance
