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COILS - Mcf-B65

FDA 510(k)

Class II (US FDA 510(k))

510(k) K071821

by Tonica Elektronik A/S

Identifiers

510(k) Number
K071821 FDA 510(k)
FDA Product Code
GWF FDA 510(k)
Models / Variants
Mcf-B65 FDA 510(k)
Mcf-75 FDA 510(k)
Mcf-125 FDA 510(k)
Cool-B65 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1870 FDA 510(k)
Regulation Number
882.1870 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

These coils are classified as Stimulator, Electrical, Evoked Response, designed to deliver controlled electrical stimulation for neurological assessment. They are configured as circular or butterfly-shaped devices with diameters ranging from 65 mm to 125 mm, enabling targeted stimulation of neural pathways during diagnostic procedures in neurology.

The coils are supplied as reusable medical devices, intended for use in clinical settings where evoked response testing is performed. The COOL-B65 model includes an external coil cooler unit for active cooling, facilitating extended operational use while integrated thermo sensors monitor surface temperature to prevent thermal injury to patients or operators. Authorised under FDA 510(k) clearance (K071821), these devices adhere to regulatory standards for Class II electrical stimulators under regulation 882.1870.

Frequently asked questions

Are these coils designed for single-use or can they be reused in clinical settings?

These coils are explicitly labeled as reusable medical devices, intended for use in clinical settings where evoked response testing is performed. Since they are designed for repeated use, proper cleaning, maintenance, and adherence to manufacturer guidelines are essential to ensure safety and performance.

What sizes are available for these coils, and how do they differ in application?

The coils come in four models with varying diameters: MCF-B65 (65 mm), MCF-75 (75 mm), MCF-125 (125 mm), and COOL-B65 (65 mm with active cooling). The COOL-B65 model includes an external cooler unit to prevent overheating during extended use, making it suitable for prolonged procedures. The other models are standard circular or butterfly-shaped coils for targeted neural stimulation.

How does the COOL-B65 model differ from the other coils in terms of functionality?

The COOL-B65 model incorporates an external coil cooler unit and integrated thermo sensors to actively monitor and regulate surface temperature. This feature allows for extended operational use without risking thermal injury to patients or operators, unlike the other models, which lack active cooling.

What regulatory pathway was followed for these coils, and what does that mean for their use?

These coils were cleared through the FDA’s 510(k) pathway (K071821) under a Special classification, determined to be substantially equivalent to a predicate device. This means they meet regulatory standards for Class II electrical stimulators (regulation 882.1870) and are authorized for use in neurological evoked response testing as described in the submission.

Are these coils intended for use in specific neurological procedures, or are they versatile for multiple diagnostic tests?

These coils are designed for neurological assessment via controlled electrical stimulation to evoke responses, making them versatile for various evoked response testing procedures in neurology. Their circular or butterfly shapes allow targeted stimulation of neural pathways, but their specific application depends on the clinical protocol and diagnostic needs of the procedure.

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: Coils, Models Mcf-b65, Mcf-75, Mcf-125 and Cool-b65 (K071821) — Fda 510 ..., PDF K071821 - Coils, Models Mcf-b65, Mcf-75, Mcf-125 and Cool-b65, COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65… - FDA.report, PDF 10(71 S'L - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Tonica Elektronik A/S

Sources (1)

  • FDA 510(k) K071821 24 fields · synced Oct 6, 2026