21 CFR 890.1175 — Cable, Electrode
Physical Medicine (PM) · Part 890 Subpart B—Physical Medicine Diagnostic Devices · § 890.1175
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IKD | Cable, Electrode | 2 | 6 |
Special Controls
IKD — Cable, Electrode
*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.
eCFR
IKD — Cable, Electrode
(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.”
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