M AND R REUSABLE ELECTRODES (MULTIPLE)

K963125 · M & R Mfg., Inc. · GZJ · Feb 6, 1997 · Neurology

Device Facts

• Record ID: K963125
• Device Name: M AND R REUSABLE ELECTRODES (MULTIPLE)
• Applicant: M & R Mfg., Inc.
• Product Code: GZJ · Neurology
• Decision Date: Feb 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

M&R Reusable Electrodes are flexible, laminated cutaneous electrodes designed to interface between standard TENS/NMES stimulation devices and patient skin. They deliver electrical stimulation for pain management or neuromuscular therapy. The device consists of various backing materials (polyester, polyethylene foam, tricot), conductive elements (conductive rubber, conductive film, Ag/AgCl coating), and biocompatible conductive gels. They are available in multiple sizes and shapes with either direct pin lead wire connections or integral pre-wired leads. Used in clinical or home settings, the electrodes are applied by the patient or clinician to the skin surface. They are intended for single-patient, multiple-application use. By providing a stable electrical interface, they facilitate the delivery of therapeutic currents from the stimulator to the target tissue, potentially reducing pain or improving muscle function.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material composition, and intended use comparisons to the predicate device.

Technological Characteristics

Laminated, flexible cutaneous electrodes. Materials: polyester, polyethylene foam, tricot, conductive rubber, conductive film, Ag/AgCl coating, biocompatible adhesive, and conductive gel. Connectivity: standard .080 in. female pin connectors or integral lead wires. Compatible with standard TENS/NMES devices. Multi-model form factor (37 variations).

Indications for Use

Indicated for patients requiring TENS or NMES therapy for pain management or neuromuscular stimulation. Compatible with standard TENS/NMES devices. Contraindicated for patients with known sensitivity to electrode materials or adhesives.

Regulatory Classification

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.

Predicate Devices

• Medi-Source, Inc. GeoHesive Reusable Electrodes (K903402)

Submission Summary (Full Text)

{0}

FEB - 6 1997
K963125

M & R MANUFACTURING
Telephone [phone]

11987 Upper Fredericktown Amity Rd.
Fredericktown, OH 43019

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 Electrical Nerve Stimulator (TENS) and Neuromuscular 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 single-patient/multiple-application use in TENS ("traditional" TENS, microcurrent TENS, etc.) or NMES ("traditional" NMES, interferential, high-volt pulsed galvanic, functional electrical stimulation, etc.).

Predicate Device: Medi-Source, Inc. GeoHesive Reusable 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
Secretary & Treasurer
M & R Manufacturing, Inc.
11967 Upper Fredericktown Amity Road
Fredericktown, Ohio 43019
614/694-6511
101

{1}

Device Comparison Chart

| Device Characteristic | Medi-Source GeoHesive Reusable Electrodes - K903402 | M&R Reusable Electrodes |
| --- | --- | --- |
| 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
2. 1.875 x 1.875 clover leaf
3. 2.875 x 1.875 dog bone
4. 1.875 x 1.875 square
5. 2.000 x 1.250 rectangle
6. 1.750 x 1.625 rectangle
7. 3.875 x 1.875 rectangle
8. 3.875 x 2.500 rectangle *
9. 6.000 x 3.875 butterfly
10. 1.875 dia. round
11. 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

2. Polyester/polyester film laminate w/ adhesive
Conductive rubber strip
Biocompatible gel

3. Polyethylene foam w/ adhesive
Conductive rubber strip
Biocompatible gel

4. Tricot/polyester laminate
Conductive rubber strip
Biocompatible gel |

{2}

Device Comparison Chart (cont.)

| Device Characteristic | Medi-Source GeoHesive Reusable Electrodes - K903402 | M&R Reusable Electrodes |
| --- | --- | --- |
| 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 |

{3}

Device Comparison Chart (cont.)

| 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 |

{4}

Device Comparison Chart (cont.)

| 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)
2. 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 |