Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
Device Facts
| Record ID | K261442 |
|---|---|
| Device Name | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array |
| Applicant | Cadwell Industries, Inc. |
| Product Code | GXY · Neurology |
| Decision Date | Jun 26, 2026 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
Charlotte Surface Electrode Arrays are indicated for non-invasive use with recording and monitoring equipment to acquire physiological electrical signals from Electromyography (EMG), Electroencephalograph (EEG), and Evoked Potentials (EP).
Device Story
Charlotte Surface Electrode Arrays consist of surface electrodes assembled with connectors or printed circuit boards; optionally affixed to a proprietary carrier. Device functions as a passive interface to acquire physiological electrical signals (EMG, EEG, EP) from patient skin; requires use of FDA-cleared conductive paste. Operated by medical professionals in clinical settings; connects to compatible recording/monitoring equipment via proprietary latching mechanism. Output is raw electrical signal transmitted to monitoring device for clinical interpretation. Benefits include non-invasive signal acquisition for diagnostic monitoring.
Clinical Evidence
Bench testing only. Performance data included electrical characterization per ANSI/AAMI EC12 (AC impedance, offset voltage, combined offset instability/noise, bias current voltage). Biocompatibility established via identical material composition to predicate and history of safe use for skin-contacting materials per FDA 2023 guidance.
Technological Characteristics
Materials: Disposable (Ag/AgCl, ABS); Reusable (Ag, Ag/AgCl, or Au-plated). Sensing: Passive cutaneous electrode. Connectivity: Proprietary latching connector. Form factor: Electrode array assembly with optional carrier. Sterilization: Non-sterile. Standards: ANSI/AAMI EC12 for electrical performance.
Indications for Use
Indicated for adults and pediatric patients requiring non-invasive acquisition of physiological electrical signals (EMG, EEG, EP) for use with recording and monitoring equipment. Prescription use only.
Regulatory Classification
Identification
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.
Predicate Devices
- Technomed Cutaneous Electrodes (K072016)
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 26, 2026
Jason Ford
Regulatory Affairs Manager
Cadwell Industries, Inc.
909 N Kellogg St.
Kennewick, Washington 99336
Re: K261442
Trade/Device Name: Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array
Regulation Number: 21 CFR 882.1320
Regulation Name: Cutaneous Electrode
Regulatory Class: Class II
Product Code: GXY
Dated: April 30, 2026
Received: April 30, 2026
Dear Jason Ford:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K261442 - Jason Ford
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(https://www.fda.gov/media/99812/download) and 'Deciding When to Submit a 510(k) for a Software Change to an Existing Device' (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ('UDI Rule'). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, 'Misbranding by reference to premarket notification' (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K261442 - Jason Ford
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Sincerely,
For Tushar Bansal
Acting Assistant Director
DHT5B: Division of Neuromodulation and
Physical Medicine Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K261442 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array | | |
| Please provide your Indications for Use below. | | ? |
| Charlotte Surface Electrode Arrays are indicated for non-invasive use with recording and monitoring equipment to acquire physiological electrical signals from Electromyography (EMG), Electroencephalograph (EEG), and Evoked Potentials (EP). | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
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# Electrode Array 510(k) Summary K261442
## Submitter Information
| Submitter Name: | Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, Washington 99336 |
| --- | --- |
| Submitter Phone: | 509-735-6481 |
| Contact Person: | Jason Ford Regulatory Affairs Manager |
| Date Summary Prepared: | June 25, 2026 |
## Subject Device
| Trade Name: | Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode Array |
| --- | --- |
| Common Name: | Cutaneous Electrode |
| Classification Name: | 21 CFR section 882.1320 |
| Product Code: | GXY |
## Predicate Device
| 510(k) Number: | K072016 |
| --- | --- |
| Trade Name: | Cutaneous Electrodes |
| Submitter Name: | Technomed Europe |
| Classification Name: | Neurology 21 CFR 882.1320 |
| Product Code: | GXY |
## Device Description
Charlotte Surface Electrode Arrays consist of an assembly of surface electrodes terminated to one or more connectors or printed circuit boards. The arrays are intended to record the indicated monitored physiological signals in a non-invasive manner. The electrodes are provided non-sterile. Optionally, Surface Electrode Arrays may be affixed to a proprietary carrier intended to facilitate a Surface Electrode Array’s connection with separately FDA-cleared compatible recording devices.
The device is intended to be used with FDA-cleared electrode conductive paste.
Available as Single-use disposable assemblies, or reusable assemblies.
## Indications for Use
Charlotte Surface Electrode Arrays are indicated for non-invasive use with recording and monitoring equipment to acquire physiological electrical signals from Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP).
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## Electrode Array 510(k) Summary K261442
### Summary of Technological Characteristics and Comparison to the predicate devices
**Table 1**
| *Characteristics* | *Subject Device Charlotte ACC25 Surface Electrode Array; CharlotteACC25 Reusable Surface Electrode Array (K261442)* | *Predicate Device Technomed Cutaneous Electrodes (K072016)* | *Discussion of Major Differences* |
| --- | --- | --- | --- |
| *Device Class* | Class II | Class II | No differences |
| Class Name | Cutaneous Electrode | Cutaneous Electrode | No differences |
| Product Code | GXY = Electrode, Cutaneous | GXY = Electrode, Cutaneous | No differences |
| Regulation | 882.1320 | 882.1320 | |
| Intended User | Medical Professional | Medical Professional | No differences |
| Target Patient Population | Adults and Pediatric | Adults and Pediatric | No differences |
| Prescription | Prescription use only | Prescription use only | No differences |
| Type of Use | Single Use, Reusable | Single Use, Reusable | No differences |
| Indications for Use | Charlotte Surface Electrode Arrays are indicated for non-invasive use with recording and monitoring equipment to acquire physiological electrical signals from Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials (EP). | The cup electrodes are intended for non-invasive use with recording and monitoring equipment (active and reference), of Electromyography (EMG), Electroencephalograph (EEG) and Evoked Potentials. | No significant differences |
| Electrode Materials | Disposable: Silver/Silver Chloride (Ag/AgCl); Acrylonitrile Butadiene Styrene (ABS) Reusable: Ag, Ag/AgCl, or Gold (Au)-plated. | Disposable: Ag/AgCl; ABS Reusable: Ag/AgCl, Au-plated | No differences |
| Electrode Connector | Proprietary connection with latching mating mechanism | DIN 42-802 touch proof connector | These design differences do not introduce new questions of safety or effectiveness |
| Safety and Performance Characteristics | Same | Same | This submission uses the Safety and Performance Based Pathway; therefore a direct comparison of the safety and performance characteristics is not required. |
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CADWELL®
# Electrode Array 510(k) Summary
K261442
Performance Data
In accordance with the FDA guidance document, “Cutaneous Electrodes for Recording Purposes-Performance Criteria for Safety and Performance Based Pathway”, issued on August 14, 2020, the following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination.
Electrode Characterization:
- Electrical Performance per FDA-recognized consensus standard, ANSI/AAMI EC12
Disposable ECG Electrodes
- AC Impedance
- Offset Voltage
- Combined offset instability and internal noise
- Bias Current Voltage (DC Voltage Offset)
Sufficient justification was provided to ensure the device characteristics of shelf life and conductive connection compliance considerations under the Cutaneous Electrodes guidance did not impact the safety and effectiveness of the subject device.
Biocompatibility
The biocompatibility of the subject device is based upon verified claims of identical materials of construction compared to the predicate devices, as well as on the use of skin-contacting, low biocompatibility risk materials with a long history of safe use in accordance with Attachment G of the FDA’s 2023 Biocompatibility Guidance.
Summary of Non-clinical Testing
Safety and Performance bench testing of Charlotte Surface Electrode Arrays that confirm the claimed performance characteristics of the subject device. The results of the completed evaluations and testing demonstrate that any differences relative to the predicate device do not raise different questions of safety and effectiveness. Therefore, the performance data demonstrate acceptable safety and performance compared to the predicate devices.
Conclusion
The Charlotte ACC25 Surface Electrode Arrays have the same intended use as the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness, and the performance data demonstrate that the Charlotte ACC25 Surface Electrode Arrays are substantially equivalent to the cleared predicate device.
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