(88 days)
Not Found
No
The device description and intended use are for simple disposable electrodes, and there is no mention of AI or ML in the provided text.
Yes
The device is described as electrodes intended for use in TENS and NMES applications, both of which are therapeutic modalities for pain relief and muscle stimulation, respectively.
No
Explanation: The device is described as electrodes intended for TENS and NMES applications, which are therapeutic (stimulation) uses, not diagnostic.
No
The device description explicitly states it is a physical product (laminated, flexible structures composed of materials like cloth, conductive rubber, and conductive gel) and does not mention any software component.
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 TENS and NMES applications. These are therapeutic applications involving electrical stimulation applied to the body, not diagnostic tests performed on samples taken from the body.
- Device Description: The description details the physical components and how they function in delivering electrical stimulation. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the M&R Disposable Electrodes are a medical device used for therapeutic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
M&R Disposable Electrodes are intended for single-patient/singleapplication 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.
Product codes
84GXY
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.
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)
Medtronic ComfortEase Disposable TENS and NMES Electrodes, Medical Designs, Inc. Protector Disposable TENS and NMES Electrodes
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
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.(b)
Classification. Class II (performance standards).
0
NOV 1 5 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/singleapplication 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:
Mare E. Haley
Mark E. Dailey, Presiden M & R Manufacturing, Inc. 11967 Upper Fredericktown Amity Road Fredericktown, Ohio 43019 614/694-6511
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)
- 2.0 x 3.5 in. (rectangle)
- 1.5 x 3.0 in. (butterfly) | 1) 2.0 x 2.25 in. (rectangle)
- 2.0 x 2.75 in. (rectangle)
- 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:
- Polyester w/ biocompatible
adhesive
Conductive film w/ or w/o Ag/
AgCl coating
Lead wire assembly
Biocompatible gel - 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 - Polyester w/ biocompatible
adhesive
Conductive foil
Male snap connector
Biocompatible gel |
| 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) - 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 |
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