Identifiers
- 510(k) Number
- K851303 FDA 510(k)
- FDA Product Code
- GXY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1320 FDA 510(k)
- Regulation Number
- 882.1320 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Comfort-Ease Electrode is a cutaneous electrode designed for transcutaneous electrical stimulation and monitoring applications. Classified under product code GXY, it is intended for use in neurological assessments and treatments, facilitating nerve stimulation or signal detection through direct skin contact.
This device is supplied as a single-use or reusable component, depending on clinical practice and facility protocols. It is regulated under FDA 510(k) clearance (K851303) with a decision of Substantially Equivalent, issued in 1985. No specific sterility or MRI safety information is provided in the data, though standard clinical hygiene practices should be followed during use.
Frequently asked questions
What clinical applications is the Comfort-Ease Electrode primarily used for, and how does it function?
The Comfort-Ease Electrode is designed for transcutaneous electrical stimulation and monitoring, specifically in neurological assessments and treatments. It works by facilitating nerve stimulation or signal detection through direct skin contact, enabling clinicians to deliver targeted electrical impulses or measure nerve responses during procedures like nerve conduction studies or neuromuscular evaluations.
Is the Comfort-Ease Electrode intended for single-use or can it be reused? How should facilities decide?
The Comfort-Ease Electrode can be used either as a single-use or reusable component, depending on the clinical practice and facility protocols. Facilities should establish their own guidelines based on factors like infection control, patient safety, and cost-effectiveness, ensuring adherence to standard clinical hygiene practices in either case.
What regulatory pathway was followed for FDA clearance of the Comfort-Ease Electrode, and when was it approved?
The Comfort-Ease Electrode received FDA clearance through a 510(k) submission (K851303) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) issued on May 23, 1985. The advisory committee involved was the Neurology (NE) panel, reflecting its intended use in neurological applications.
Are there any specific storage instructions or considerations for the Comfort-Ease Electrode?
While the provided data does not specify storage instructions, standard clinical hygiene practices should be followed to maintain the electrode’s integrity. This includes protecting it from moisture, extreme temperatures, and contamination, especially if reused. Facilities should consult manufacturer guidelines for optimal storage conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: COMFORT-EASE ELECTRODE (K851303) - FDA 510 (k), COMFORT-EASE ELECTRODE (K851303) — FDA 510 (k) | Innolitics, Comfort-ease Electrode 510 (k) K851303 - FDA.report, Comfort-ease Electrode 510 (k) K851303 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K851303 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K851303 24 fields · synced Oct 6, 2026