PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Device Description

The Axelgaard PALS® Neurostimulation reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS.

The device functions as a passive device by carrying an electrical signal from a neurostimulation device through the device cable and electrode lead wire to the user skin. It is composed of a cover, connector lead wire, strelchable conductive fabric, conductive hydrogel, and an electrode carrier distribution is delivered via a connector lead wire stripped to an additional length.

AI/ML Overview

The provided document is a 510(k) summary for the Axelgaard PALS® Neurostimulation Electrodes. It is a premarket notification for a medical device seeking clearance from the FDA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies.

Therefore, the document explicitly states: "No performance data is required to support the proposed over-the-counter PALS® Neurostimulation Electrode as it has identical technical characteristics (including design) as compared to the predicate device."

Because no performance data or clinical studies are presented in this document to demonstrate the device meets specific acceptance criteria, I cannot provide the requested information. The 510(k) process for this device relies on the established safety and effectiveness of its predicate devices, not on new clinical trials for the subject device itself.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Axelgaard Manufacturing Co., LTD. The logo features a stylized "A" with horizontal lines inside, followed by the text "AXELGAARD" in bold, uppercase letters. Below "AXELGAARD" is the text "MANUFACTURING CO., LTD." in a smaller font size.

FEB 1 3 2014

005 PALS 510K_Summary_2_5_2014

510(k) Summary 807.92(c)

Submitter/Contact Person	Dan Jeffery, PresidentAxelgaard Manufacturing Co., Ltd.520 Industrial WayFallbrook, CA 92028Phone: 760-451-8000 Fax: 760-723-2350Dan.jeffery@axelgaard.com
Device Identification
Common Name:	Electrodes, Cutaneous
Trade Name/Common Name:	PALS® Neurostimulation Electrodes
Regulation No.:	21CFR 882.1320 Electrodes, Cutaneous
Classification:	Class II
Product Code:	GXY

Device Description (807.92[a] [4])

The Axelgaard PALS® Neurostimulation reusable self-adhering electrode is used as a transcutaneous electrical nerve stimulation electrode in conjunction with an electrical stimulator for TENS or EMS.

Technical Characteristics

Axelgaard Manufacturing manufactures the PALS® Neurostimulation Over the Counter Electrode and the ValuTrode Over the Counter Neurostimulation Electrodes (K13987) with the same conductive hydrogel, and electrode carrier.

Everyway Medical manufactures the Lifecare Electrode (K083302) with the same conductive hydrogel and conductive carbon film as Axelgaard's ValuTrode Neurostimulation Electrodes (K130987). Axelgaard Manufacturing supplies these components to Everyway.

Intended Use (807.92[a] [5])

Legally Marketed Predicate Devices (807.92[a] [3]}

Device Name	Manufacturer	510(k) No.	Date Cleared		Subject DeviceAxelgaard PALS® Neurostimulation OTC	Axelgaard PALS Flex(K874469)	Everyway Lifecare(K083302)	Axelgaard ValuTrode OTC(K130987)		Subject DeviceAxelgaard PALS® NeurostimulationOTC	Axelgaard PALS® Flex(K874469)	Everyway Lifecare(K083302)	Axelgaard ValuTrode OTC(K130987)
PALS® Flex Neurostimulation Electrodes	Axelgaard Manufacturing Co., Ltd.	K874469	1998		Cutaneous electrode which conducts anelectrical signal from a neurostimulationdevice through a leadwire; which isdispersed from the leadwire across astretchable conductive fabric thentransmitted through the conductiveadhesive gel to the surface of the user'sskin.	Cutaneous electrode which conductsan electrical signal from aneurostimulation device through aleadwire; which is dispersed from thewire across a stretchable conductivefabric then transmitted through theconductive adhesive gel to the surfaceof the user's skin.	Cutaneous electrode whichconducts an electrical signalfrom a neurostimulationdevice through a leadwire;which is dispersed from thewire across a conductivesurface; then transmittedthrough the conductiveadhesive gel to the surfaceof the user's skin. Theelectrode connection point(leadwire) is compatible withstandard, marketedNeurostimulation devices.The device is safe andeffective as the predicatedevices cited (within their510(k) submittal).	Cutaneous electrode which conductsan electrical signal from aneurostimulation device through aleadwire (or snap); which isdispersed from the leadwire/snapacross a conductive surface; thentransmitted through the conductiveadhesive gel to the surface of theuser's skin.	Features /Materials	Four basic components:Top cover material Lead wire connection Lead wire has insulation on female connector Stretchable conductive fabric Conductive hydrogel	Four basic components:Top cover material Lead wire connection Lead wire has insulation on female connector Stretchable conductive fabric Conductive hydrogel	Four basic components:Top cover material Lead wire connection Lead wire has insulation on female connector Conductive carbon film Conductive hydrogel	Four basic components:Top cover material Lead wire or snap connection Lead wire has insulation on female connector Conductive carbon film Conductive hydrogel
Life Care Electrodes	Everyway Medical Instruments Co.	K083302	2009		Safety & Effectiveness-Based on successful biocompatibilitytesting of the skin contacting conductivehydrogel, the electrical performance ofthe insulated leadwire components andelectrode current distribution test results,the PALS® Neurostimulation devicesare safe and effective when used as aninterface between a user's skin and anapproved neurostimulation devices.	Safety & Effectiveness-Based on successful biocompatibilitytesting of the skin contactingconductive hydrogel, the electricalperformance of the insulated leadwirecomponents and electrode currentdistribution test results, the PALS®Flex neurostimulation devices are safeand effective when used as aninterface between a user's skin and anapproved neurostimulation devices.		Safety & Effectiveness-Based on successful biocompatibilitytesting of the skin contactingconductive hydrogel, the electricalperformance of the snap/insulatedleadwire components and electrodecurrent distribution test results, theValuTrode neurostimulation devicesare safe and effective when used asan interface between a user's skinand an approved neurostimulationdevices.	Indications ofUse	PALS® reusable, self-adhering, over-the-counter NeurostimulationElectrodes are indicated for use with transcutaneous electrical stimulation devices.	The Axelgaard PALS® Flex electrode is a reusable disposable device which adheres to the patient over the entire surface of the electrode. The device is intended to be used in connection with any neurostimulation approved for distribution within the USA.	Electrodes are intended for use with transcutaneous neurostimulation devices as over the counter devices.	ValuTrode® reusable, self-adhering, over-the-counter NeurostimulationElectrodes are indicated for use with transcutaneous electrical stimulation devices.
ValuTrode® Neurostimulation Over theCounter Electrodes	Axelgaard Manufacturing Co., Ltd.	K130987	2013		Our labeling indicates consulting thestimulator manual for proper electrodesize and placement. Do not exceed 0.1watts/cm2.	Our labeling states: "Consult stimulatormanual for proper electrode size. Donot exceed 0.1 watts/cm2."		Our labeling indicates consulting thestimulator manual for properelectrode size and placement. Do notexceed 0.1 watts/cm2.	Principles ofOperation	Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices.Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.		Some common type of neurostimulation devices include, but are not limited to, TENS and EMS devices.Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.	Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electrical muscle stimulation (EMS) devices.Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.
	FDA max power guidelines draftguidance 2010 states in Section D.(vi)a maximum average power densitythat does not exceed .025 watts persquare centimeter of electrodeconductive surface area.	FDA max power guidelines draftguidance 2010 states in SectionD.(vi) a maximum average powerdensity that does not exceed .025watts per square centimeter ofelectrode conductive surface area.		FDA max power guidelines draftguidance 2010 states in SectionD.(vi) a maximum average powerdensity that does not exceed .025watts per square centimeter ofelectrode conductive surface area.	Differences	PALS® Neurostimulation electrodes will offer lead wire connection configurations.PALS® electrodes utilize a stretchable conductive fabric.We claim that these electrodes can be sold as OTC (over-the-counter) under the 510(k) regulation (21 CFR 801 Subpart C) requiring 510(k) submittal.	PALS® Flex electrodes offer lead wire connection configurationsPALS® Flex electrodes utilize a stretchable conductive fabric.The devices are sold as prescription only devices.	The Lifecare Electrode 510(k) only offers lead wire connection electrodes.Lifecare Electrodes utilize conductive film.Lifecare Electrodes are sold as over-the-counter devices.	ValuTrode® over the counter electrodes offer lead wire and snap connection configurations.Axelgaard ValuTrode® electrodes utilize conductive film.The devices are sold as over-the-counter devices.

(The Substantial Equivalency Summary and subsequent pages are formatted in landscape orientation for ease of reading.)

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JA = AXELGAARD

Substantial Equivalence Summary (807.92[a] [6])

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NS MANUFACTURING CO., LTD.

005-3

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Performance Data

No performance data is required to support the proposed overhe-counter PALS® Neustimulation Electode has ieafical technol
characteristics (including design) as compared to be

Safety / Effectiveness and Conclusion Statement (860.

xelgaard Manufacturing Co., Ltd. considers the PALS® over the-counter Neurostimulation electrode to be as safe and effective as the predicated devices PAL
lex (K874469) and

upon an evaluation of the proposed PALS® electrode, compared with he Lifest on the closes, Axegard Manufacum
d. believes that the proposed PALS® self alheing reusable Neurost

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 13, 2014

Axelgaard Manufacturing Co., Ltd. Mr. Dan Jeffery, President 520 Industrial Way Fallbrook, CA 92028

Re: K132422

Trade/Device Name: PALS® Neurostimulation Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrodes Regulatory Class: Class II Product Code: GXY Dated: November 18, 2013 Received: November 19, 2013

Dear Mr. Jeffery:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Dan Jeffery

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

Carlos Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132422

Device Name

PALS® Neurostimulation Electrodes

Indications for Use (Describe)

PALS® reusable, self-adhering, over-the-counter Neurostimulation Electrodes are indicated for use with transcutaneous electrical stimulation devices. Some common types of transcutaneous stimulation devices include, but are not limited to, transepithelial nerve stimulation (TENS) and electical muscle stimulation (EMS) devices. Transcutaneous Neurostimulation Electrodes are passive devices serving as an interface between a user's skin and a neurostimulation device.

Type of Use (Select one or both, as applicable)

] Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

PSC Publishing Scrivices (301) 443-6740 2

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Regulation Number and Section

§ 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).