M & R DISPOSABLE ELECTRODE (14200)

K963236 · M & R Mfg., Inc. · GXY · Nov 15, 1996 · Neurology

Device Facts

• Record ID: K963236
• Device Name: M & R DISPOSABLE ELECTRODE (14200)
• Applicant: M & R Mfg., Inc.
• Product Code: GXY · Neurology
• Decision Date: Nov 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

M&R Disposable Electrodes are laminated, flexible cutaneous electrodes designed for TENS and NMES applications. The device consists of a polyester backing with biocompatible adhesive, a conductive element (rubber strip, film, or foil with optional Ag/AgCl coating), and a biocompatible conductive gel. It features a standard .080-inch female lead wire pin connection or male snap assembly. The electrodes are applied to the patient's skin by a clinician or the patient to interface with standard TENS/NMES stimulation devices. The device delivers electrical current from the stimulator to the target tissue to facilitate nerve or muscle stimulation. Intended for single-patient, single-application use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material composition, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Laminated, flexible cutaneous electrodes. Materials: polyester backing, biocompatible adhesive, conductive rubber/film (with optional Ag/AgCl coating), and biocompatible conductive gel. Connection: standard .080-inch female pin or male snap. Dimensions: 2.0x2.0 in. to 3.0x6.0 in. range. Single-use. Passive device; no energy source or software.

Indications for Use

Indicated for patients requiring TENS or NMES therapy for nerve or muscle stimulation. No specific age or gender restrictions provided. Contraindicated for patients with known sensitivity to adhesives or gels if skin irritation occurs.

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

• Medtronic ComfortEase Disposable TENS and NMES Electrodes (K851303)
• Medical Designs, Inc. Protector Disposable TENS and NMES Electrodes (K911366A)

Submission Summary (Full Text)

{0}

K963236

NOV 15 1996

M & R Manufacturing, Inc.
M&R Disposable 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: Mark E. Dailey

Date Prepared: 12 August 1996

Proprietary Name: M&R Disposable Electrodes

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

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

Device Description: M&R Disposable Electrodes are laminated, flexible structures composed of materials commonly used in this application (e.g., cloth with biocompatible adhesive, conductive rubber, and biocompatible conductive gel). The electrodes have a direct lead wire pin connection design and are compatible with all standard, marketed TENS and NMES stimulation devices.

Intended Use: M&R Disposable Electrodes are intended for single-patient/single-application use in TENS ("traditional" TENS, microcurrent TENS, etc.) and NMES ("traditional" NMES, interferential NMES, high-volt pulsed galvanic NMES, functional electrical stimulation (FES), etc.) applications.

Predicate Devices: Medtronic ComfortEase Disposable TENS and NMES Electrodes, and Medical Designs, Inc. Protector Disposable TENS and NMES Electrodes. A chart comparing characteristics of M&R Disposable Electrodes to the predicate devices, demonstrating substantial equivalence, is attached.

Submitted by:

Mark E. Dailey

Mark E. Dailey, President
M & R Manufacturing, Inc.
11967 Upper Fredericktown Amity Road
Fredericktown, Ohio 43019
614/694-6511

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{1}

| Device Characteristic | M & R Manufacturing., Inc.
M&R Disposable TENS & NMES Electrodes | Medtronic ComfortEase
Disposable TENS & NMES
Electrodes - K851303 | Medical Designs, Inc.
Protector Disposable TENS &
NMES Electrodes - K911366A |
| --- | --- | --- | --- |
| Number of Models | 1 model* | 3 models | 4 models |
| Electrode Sizes (in.)/Shapes | 2.0 x 2.25 in. (rectangle)
* Additional models of various sizes will be added within size range of: 2.0 x 2.0 in. (min.) and 3.0 x 6.0 in. (max.). | 1) 2.2 x 2.5 in. (rectangle)
2) 2.0 x 3.5 in. (rectangle)
3) 1.5 x 3.0 in. (butterfly) | 1) 2.0 x 2.25 in. (rectangle)
2) 2.0 x 2.75 in. (rectangle)
3) 2.5 x 6.0 in. (rectangle) |
| Electrode Construction | Polyester w/ biocompatible adhesive
Conductive rubber strip
Biocompatible gel

* Additional models of the above and following constructions will be added:
1) Polyester w/ biocompatible adhesive
Conductive film w/ or w/o Ag/AgCl coating
Lead wire assembly
Biocompatible gel
2) Polyester w/ biocompatible adhesive
Conductive film w/ or w/o Ag/AgCl coating
Male snap assembly
Biocompatible gel | Polyester w/ biocompatible adhesive
Conductive rubber strip
Biocompatible gel | 1) Polyester w/ biocompatible adhesive
Conductive rubber strip
Biocompatible gel

2) Polyester w/ biocompatible adhesive
Conductive foil
Male snap connector
Biocompatible gel |

{2}

| Device Characteristic | M & R Manufacturing., Inc.
M&R Disposable TENS & NMES Electrodes | Medtronic ComfortEase
Disposable TENS & NMES Electrodes - K851303 | Medical Designs, Inc.
Protector Disposable TENS & NMES Electrodes - K911366A |
| --- | --- | --- | --- |
| Lead Wire Connector Type | Std. .080 in. female connection
(hole in conductive rubber strip) | Std. .080 in. female connection
(hole in conductive rubber strip) | 1) Std. .080 in. female connection
(hole in conductive rubber strip)
2) Std. wire snap connector |
| Labeled as Reusable or Single-Use / Disposable? | Single-Use / Disposable | Single-Use / Disposable | Single-Use / Disposable |
| Indications For Use | TENS & NMES | TENS & NMES | TENS & NMES |
| Potential adverse effects | Skin irritation | Skin rash | Skin irritation |