M AND R REUSABLE ELECTRODES (MULTIPLE)

• K Number: K963125
• Device Name: M AND R REUSABLE ELECTRODES (MULTIPLE)
• Manufacturer: M & R MFG., INC.
• Date Cleared: 1997-02-06 ( 178 days)
• Product Code: GZJ
• Regulation Number: 882.5890

Intended Use

M&R Reusable Electrodes are intended for singlepatient/multiple-application use in TENS ("traditional" TENS, NMES ("traditional" NMES , microcurrent TENS, etc.) or interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).

Device Description

M&R Reusable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., various cloths, tapes, etc. with biocompatible adhesive, various electrical conductors, and various biocompatible conductive gels). The electrodes are available in models of various sizes with either direct pin lead wire connection or via an integral electrode "prewire" lead wire, and are compatible with all standard, marketed TENS and NMES stimulation devices.

Predicate Devices

K903402

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use describe a passive electrode, and there is no mention of AI, ML, or any computational processing.

Therapeutic

Yes
The device is intended for use in TENS or NMES, which are therapeutic modalities for muscular and neurological conditions.

Diagnostic

No
The description states the device is intended for use with TENS or NMES stimulation devices, which are therapeutic rather than diagnostic. The electrodes transmit electrical currents for stimulation, not for detecting or analyzing physiological conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical product composed of materials like cloth, tapes, conductors, and gels, and is compatible with TENS and NMES stimulation devices, indicating it is a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the electrodes are for use in TENS, NMES, and other electrical stimulation therapies. These are therapeutic applications, not diagnostic tests performed on samples taken from the body (which is the definition of an in vitro diagnostic).
• Device Description: The description details the physical components of the electrodes and their compatibility with stimulation devices. There is no mention of analyzing biological samples or providing diagnostic information.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing biological samples (blood, urine, tissue, etc.)
  • Detecting or measuring substances in biological samples
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions

Therefore, the M&R Reusable Electrodes are a therapeutic device used for electrical stimulation, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

M&R Reusable Electrodes are intended for singlepatient/multiple-application use in TENS ("traditional" TENS, NMES ("traditional" NMES , microcurrent TENS, etc.) or interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).

Product codes

84GXY

Device Description

M&R Reusable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., various cloths, tapes, etc. with biocompatible adhesive, various electrical conductors, and various biocompatible conductive gels). The electrodes are available in models of various sizes with either direct pin lead wire connection or via an integral electrode "prewire" lead wire, and are compatible with all standard, marketed TENS and NMES stimulation devices.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K903402

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).

Summary

0

K963123

FEB - 6 1997

M & R MANUFACTURING

T

turn. OH 430 ft

M & R Manufacturing, Inc. M&R Reusable Electrodes 510 (k) Summary of Safety and Effectiveness

The following information is submitted in accordance with the requirements of 21 CFR $807.92:

Contact Person: Russell A. Latimer

Date Prepared: 30 July 1996

Proprietary Name: M&R Reusable Electrodes

Common/Usual Name: Reusable electrodes for Transcutaneous Stimulator (TENS) and Neuromuscular Electrical Nerve Electrical Stimulation (NMES)

Classification Name: Electrodes, cutaneous (84GXY); Class II in accordance with 21 CFR § 882.1320

Device Description: M&R Reusable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., various cloths, tapes, etc. with biocompatible adhesive, various electrical conductors, and various biocompatible conductive gels). The electrodes are available in models of various sizes with either direct pin lead wire connection or via an integral electrode "prewire" lead wire, and are compatible with all standard, marketed TENS and NMES stimulation devices.

Intended Use: M&R Reusable Electrodes are intended for singlepatient/multiple-application use in TENS ("traditional" TENS, NMES ("traditional" NMES , microcurrent TENS, etc.) or interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).

GeoHesive Reusable Predicate Device: Medi-Source, Inc. Electrodes K903402. A chart comparing characteristics of M&R Reusable Electrodes to the predicate device, demonstrating substantial equivalence, is attached.

Submitted by:

Russell A. Latimer

Russell A. Latimer Secretary & Treasurer M & R Manufacturing, Inc. 11967 Upper Fredericktown Amity Road Fredericktown, Ohio 43019 614/694-6511

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Device Comparison Chart

| Device Characteristic | Medi-Source GeoHesive Reusable M&R Reusable Electrodes
Electrodes - K903402 | |
|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of Models | 3 models | 37 models |
| Electrode Sizes (in.)/Shapes

• M&R models 33000 & 35000
  are 2-electrode assemblies,
  each being of the size
  shown (*). | 1. 2.000 x 2.000 clover leaf

2. 2.000 x 3.000 dog bone
3. 2.000 x 6.000 dog bone | 1. 1.250 x 1.250 clover leaf
4. 1.875 x 1.875 clover leaf
5. 2.875 x 1.875 dog bone
6. 1.875 x 1.875 square
7. 2.000 x 1.250 rectangle
8. 1.750 x 1.625 rectangle
9. 3.875 x 1.875 rectangle
10. 3.875 x 2.500 rectangle *
11. 6.000 x 3.875 butterfly
12. 1.875 dia. round
13. 2.750 dia. round |
    | Electrode Construction | Vinyl w/ adhesive
    Lead wire assembly w/
    conductive tab
    Conductive film w/ Ag/AgCl
    coating
    Biocompatible gel | 1. Polyester w/ adhesive
    Conductive rubber strip
    Biocompatible gel
14. Polyester/polyester film
    laminate w/ adhesive
    Conductive rubber strip
    Biocompatible gel
15. Polyethylene foam w/
    adhesive
    Conductive rubber strip
    Biocompatible gel
16. Tricot/polyester laminate
    Conductive rubber strip
    Biocompatible gel |
    | Device Characteristic | Medi-Source GeoHesive Reusable M&R Reusable Electrodes
    Electrodes - K903402 | |
    | Electrode Construction
    (cont.) | | 5. Polyester film w/adhesive
    Conductive rubber strip
    Biocompatible gel |
    | | | 6. Polyester w/ adhesive
    Conductive film
    Lead wire assembly
    Biocompatible gel |
    | | | 7. Polyester w/ adhesive
    Conductive film w/
    Ag/AgCl coating
    Lead wire assembly
    Biocompatible gel |
    | | | 8. Polyethylene foam w/
    adhesive
    Conductive film
    Lead wire assembly
    Biocompatible gel |
    | | | 9. Polyethylene foam w/
    adhesive
    Conductive film w/
    Ag/AgCl coating
    Lead wire assembly
    Biocompatible gel |
    | | | 10.Tricot/polyester laminate
    w/ adhesive
    Conductive film
    Lead wire assembly
    Biocompatible gel |
    | Device Characteristic | Medi-Source GeoHesive Reusable
    Electrodes - K903402 | M&R Reusable Electrodes |
    | Electrode Construction
    (cont.) | | 11.Tricot/polyester laminate
    w/ adhesive
    Conductive film w/
    Ag/AgCl coating
    Lead wire assembly
    Biocompatible gel
    12.Polyester/polyester film
    laminate w/ adhesive
    Conductive film
    Lead wire assembly
    Biocompatible gel
    13.Polyester/polyester film
    laminate w/ adhesive
    Conductive film w/
    Ag/AgCl coating
    Lead wire assembly
    Biocompatible gel
    14.Polyester film w/
    adhesive
    Conductive film w/
    Ag/AgCl coating
    Lead wire assembly
    Biocompatible gel |
    | Stimulator Compatibility | Common, marketed TENS & NMES
    devices | Common, marketed TENS & NMES
    devices |
    | Device Characteristic | Medi-Source GeoHesive Reusable Electrodes - K903402 | M&R Reusable Electrodes |
    | Lead Wire Connector Types | Standard .080 in. female
    connection (built-in
    electrode lead with
    connector) | 1. Standard .080 in. female
    connection (built-in
    electrode lead with
    connector)
17. Standard .080 in. female
    connection (hole in
    conductive rubber strip) |
    | Labeled as reusable or
    single-use disposable? | Reusable/for single-patient,
    multiple-application use | Reusable/for single-patient
    multiple-application use |
    | Indications For Use | TENS and NMES | TENS and NMES |
    | Stated potential adverse
    reactions | Skin irritation | Skin irritation |

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Device Comparison Chart (cont.)

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