← Product Code [GXY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY) · K963236 # M & R DISPOSABLE ELECTRODE (14200) (K963236) _M & R Mfg., Inc. · GXY · Nov 15, 1996 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K963236 ## Device Facts - **Applicant:** M & R Mfg., Inc. - **Product Code:** [GXY](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY.md) - **Decision Date:** Nov 15, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1320 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K851303.md)) - Medical Designs, Inc. Protector Disposable TENS and NMES Electrodes (K911366A) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 49 {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 | --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K963236](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GXY/K963236) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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