Cable, Electrode
An Electrode Cable is an electrical accessory used in Physical Medicine to connect surface or needle electrodes to diagnostic or therapeutic electrotherapy equipment, enabling transmission of electrical signals for neuromuscular assessment or treatment. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IKD, regulated under 21 CFR 890.1175, within the Physical Medicine medical specialty.
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Basic Information
- Product Code
- IKD
- Device Class
- FDA class 2
- Regulation Number
- 890.1175
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070926 | ELECTRODE/EXTENSION CABLES, MODELS ATAR | Jun 07, 2007 | Substantially Equivalent | Oscor, Inc. |
| K992372 | THE LEADAWAY | Oct 13, 1999 | Substantially Equivalent | Therapy Equipment, Inc. |
| K935260 | PHYSIOMETRIX CABLE ADAPTER MODIFICATION | Dec 23, 1993 | Substantially Equivalent | Physiometrix, Inc. |
| K873361 | LIFE-SPAN CABLE | Nov 09, 1987 | Substantially Equivalent | Chemfet Corp. |
| K834583 | CLEAR LEADS-RADIOTRANSPARENT WIRES | Jan 30, 1984 | Substantially Equivalent | Quinton, Inc. |
| K800934 | R2 ESU CABLE-ADAPTER MODELS 160,161 | May 20, 1980 | Substantially Equivalent | R2 Corp. |
FEI Numbers
This FDA classification entry is associated with 212 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 212 registration numbers. Click on an entry to view related FDA registrations.