← Product Code [GZJ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ) · K954951 # TAYLOR GENERAL PURPOSE MONITORING ELECTRODE (K954951) _Taylor Industries, Inc. · GZJ · May 30, 1996 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K954951 ## Device Facts - **Applicant:** Taylor Industries, Inc. - **Product Code:** [GZJ](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ.md) - **Decision Date:** May 30, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5890 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Indications for Use The Taylor TENS electrode is designed to be used in monitoring/ stimulating applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance imbalance, which can cause the pickup of 60 cycle noise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures. The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only. ## Device Story Device is a cutaneous electrode for ECG monitoring and electrical stimulation; consists of silver/silver chloride conductive coated carbon-filled polymer with attached leadwire and hypo-allergenic hydrogel adhesive. Used by healthcare professionals in clinical settings. Applied to patient skin to facilitate electrical signal transmission for monitoring or stimulation. Performance depends on proper skin preparation (cleaning/shaving/abrasion) to minimize inter-electrode impedance and baseline hum. Single-patient use. ## Clinical Evidence Bench testing only. Comparative performance testing conducted against the predicate device (Classic ECG/ Stimulating No. 1700 Series Electrode) to evaluate accuracy and electrical performance. ## Technological Characteristics Materials: Silver/Silver Chloride conductive coated carbon-filled polymer; hypo-allergenic hydrogel adhesive. Meets applicable AAMI standards. Form factor: Electrode with attached leadwire. Energy: Passive conductive interface for electrical stimulation/ECG monitoring. ## Regulatory 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 - Classic ECG/ Stimulating No. 1700 Series Electrode ([K900519](/device/K900519.md)) ## 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} K954951 # 510(k) Summary of Safety and Effectiveness ## Manufacturer/ Submitter Taylor Industries, Inc. 2995 S. Moorland Road New Berlin, WI 53151 USA ## Contact Name/ Telephone Number Michael Ballard President Taylor Industries, Inc. Phone (414) 821-5169 Date October 23, 1995 ## General Device Information ### Common/ Usual Name This device is commonly known as a stimulation electrode. ### Trade/ Proprietary Name Taylor Industries, Inc.'s trade/ proprietary name for this device is the Taylor TENS (Transcutaneous Electrical Nerve Stimulator) Electrode. ### Classification Name(s) The Taylor TENS Electrode's classification name, classification panel, and regulation citation is: 21 CFR 882.1320 Cutaneous Electrode 84GXY ## Device Classification Similar devices have been determined to be Class II devices according to the Neurological Devices Classification Panel. It is believed that this electrode will be considered to be a Class II device. ## Performance Standards Performance standards (Section 514 of the Act) have not yet been established for the device that is the subject of this premarket notification submission. ## Legally Marketed Predicate Device The Taylor TENS Electrode is substantially equivalent, with similar indications for use to the following devices which are currently legally marketed and in commercial distribution: *K900519 Classic Medical Products Classic ECG/ Stimulating No. 1700 Series Electrode ## Device Description The Taylor TENS Electrode is intended to be used as an ECG or stimulating electrode. The electrode is a Silver/ Silver Chloride conductive coated carbon filled polymer, with an attached leadwire. The adhesive that is being used is a hypo-allergenic hydrogel which allows for an adequate hold to the patient. This product meets all of the applicable AAMI Standards. ## Intended Use The Taylor TENS electrode is designed to be used in monitoring/ stimulating applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient's skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance imbalance, which can cause the pickup of 60 cycle -41- 095 {1} -42- 096 neise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures. The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only. ## Conclusion Comparative testing was done on Taylor TENS electrode and the Classic ECG/ Stimulating No. 1700 Series electrode. Test results indicate that the Taylor TENS electrode provides an equivalent level or better in performance when compared to the legally marketed predicate device when tested to the accuracy requirements as specified in the contents of the premarket notification submission. Taylor Industries, Inc. feels that the Taylor TENS Electrode is as safe and effective, and performs substantially equivalent to the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K954951](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/GZJ/K954951) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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