PL-029K12 and PL-029K13 are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.

PMS (also called EMS, Modes 1, 3, 7):

PL-029K12 and PL-029K13 are used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.

Prescription Use:

PL-029K12 and PL-029K13 are intended for the following use:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Relief of pain associated with arthritis
Temporary relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Increase of local blood flow in the treatment area
Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Device Description

The subject device delivers electric pulses generated to the user's body areas such as the back and foot through the electrodes. The devices include operating of ON/OFF button, intensity increase button, intensity decrease button, and could be attached to electrodes. The device has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains.

The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, providing heat/temperature and displaying/burning calories if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.

AI/ML Overview

The provided text is a 510(k) Summary for the JKH Stimulator Plus (K182203), which is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) unit with heating capabilities. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device's performance against pre-defined acceptance criteria through a specific study.

Therefore, the information typically required to describe acceptance criteria and a study proving a device meets them (as per the prompt's request for a table of acceptance criteria, sample size, expert involvement, etc.) is not explicitly present in this type of FDA submission document.

Here's a breakdown of why this information is missing and what is provided instead:

No specific acceptance criteria table for performance: 510(k) submissions for substantial equivalence typically don't include a detailed table of acceptance criteria for clinical performance endpoints like accuracy, sensitivity, or specificity. Instead, they demonstrate that the new device's technical characteristics and intended use are similar enough to already legally marketed predicate devices such that it raises no new questions of safety or effectiveness.
No dedicated "study" proving performance against acceptance criteria: The document refers to "Non-Clinical Tests Performed" (Section 8) but these are primarily bench tests and biocompatibility tests (e.g., IEC 60601 series, ISO 10993 series) to ensure electrical safety, electromagnetic compatibility, and safe material use, not a clinical trial or performance study against specific acceptance metrics for pain relief or muscle stimulation effectiveness.
No information on sample size (clinical), expert involvement, adjudication, MRMC studies, or specific ground truth methodologies for performance: These elements are characteristic of clinical performance studies, which are generally not a requirement for 510(k) substantial equivalence for devices like TENS units unless new questions of safety or effectiveness are raised.

Based on the provided text, I can infer and extract information relevant to the prompt's structure, but it's crucial to understand that it's from the perspective of substantial equivalence rather than meeting specific performance acceptance criteria from a pre-defined study.

Attempted Interpretation of Acceptance Criteria and "Study" Information based on K182203:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) summary for substantial equivalence, the "acceptance criteria" are implied by the comparison to a predicate device. The "reported device performance" is framed in terms of technical specifications being within ranges demonstrated by legally marketed devices, indicating no new safety or effectiveness concerns.

Category	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (JKH Stimulator Plus [PL-029K12 & PL-029K13])
Intended Use	Must be substantially equivalent to predicate devices, addressing temporary pain relief, chronic pain, arthritis pain, muscle performance, and local blood circulation via TENS/PMS, and minor aches and pains via heating.	TENS (Modes 1, 2, 4, 5, 6, 8): Temporary relief of pain associated with sore/aching muscles (shoulder, waist, back, arm, leg from exercise/activities), symptomatic relief/management of chronic/intractable pain, relief of pain associated with arthritis. PMS (Modes 1, 3, 7): Stimulate healthy muscles to improve/facilitate muscle performance, improve muscle tone/firmness, strengthen muscles (arms, abdomen, legs, buttocks), temporarily increase local blood circulation in lower extremities.Heating (PL-029K13): Temporary relief of minor aches and pains. (All match predicates).
Safety Standards	Compliance with recognized electrical safety, EMC, and biological evaluation standards.	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10, and FDA Guidance for software.
Maximum Skin Temp.	For heating function, must be within safe limits (matches predicate's max temp.).	43 °C (PL-029K13 only), matches K162517 predicate.
Electrical Output	Electrical parameters (Max. Output Voltage, Max. Output Current, Pulse Width, Frequency, Max Phase Charge, Max Current Density, Max Avg. Power Density) must be within the range of cleared predicate devices, such that they do not raise new safety or effectiveness concerns.	Values provided for both PL-029K12 and PL-029K13 across 500Ω, 2KΩ, and 10KΩ loads. These values are identical to the K162517 predicate and are stated to be within the range of other FDA-cleared transcutaneous electrical nerve stimulators, and differences from some predicates do not raise new safety/effectiveness questions.
Electrode Compatibility	Labels must ensure safe and proper use of compatible electrodes.	Labeled for use only with its own compatible electrodes. Concerns for safe and proper use fully addressed through labeling. Electrodes are the same as or biocompatible with those cleared for predicates.
Device Operation	Manual and optional wireless control should facilitate user operation without raising safety concerns.	Easily operated through buttons (ON/OFF, intensity, heat, display/burning calories). Optional wireless control via remote or Bluetooth APP.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable in the context of clinical performance for this 510(k). The "test set" here refers to the actual device units subjected to engineering bench tests and biocompatibility tests. The document does not specify the number of units tested.
Data Provenance: The tests performed are non-clinical (bench testing, biocompatibility) of the manufactured device. These tests are presumably conducted by the manufacturer or contracted labs. The origin isn't stated in terms of country or retrospective/prospective as it relates to clinical data, but rather reflects standard engineering and safety evaluations for device manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Experts for Ground Truth: Not applicable. For demonstrating substantial equivalence, "ground truth" (clinical diagnosis) is not established by experts for a specific test set. Rather, the device's technical specifications are compared to those of established, legally marketed predicate devices. The expertise involved would be internal engineering and regulatory expert(s) at JKH USA, LLC, and the FDA reviewers themselves, evaluating the submission for regulatory compliance and equivalence.

4. Adjudication method for the test set

Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in the context of this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: No. This device is a TENS/PMS unit, not an AI-powered diagnostic imaging tool. Therefore, an MRMC comparative effectiveness study is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: Not applicable. This device does not have an AI algorithm. It is a direct electrical stimulation device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable in the clinical sense. For a 510(k) demonstrating substantial equivalence for a TENS/PMS device, the "ground truth" for regulatory approval lies in conforming to recognized safety and performance standards (bench testing) and demonstrating that its technological characteristics and intended uses are the same as or similar enough to already legally marketed predicate devices that it does not raise new questions of safety or effectiveness. The effectiveness of the class of device is established through prior predicate device clearances.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

Summary of what the document does provide regarding "proof":

The "proof" in this 510(k) summary is based on technical comparison and compliance with voluntary standards, not clinical performance studies against specific acceptance criteria.

Technical Comparison (Section 6 & 7): The core of the substantial equivalence argument is presented in "Table 1. Comparison between the subject device and the predicate device" and the subsequent "Summary of Substantial Equivalence" (Section 7). This table systematically compares the JKH Stimulator Plus (K182203) to multiple predicate devices (K162517, K031017, K140333, K153704) across various features including:
- Intended Use (for both OTC and Prescription uses)
- Power Source
- Compliance with Voluntary Standards (electrical safety, EMC, biocompatibility)
- Functions and Design (Electrical stimulation and heat)
- Maximum skin temperature (for heating mode)
- Electrical Output Parameters (Maximum output voltage, current, pulse width, frequency, phase charge, current density, average power density at various loads).
Conclusion of Equivalence (Section 7): The document argues that:
- The subject device (JKH Stimulator Plus) is identical to one of the predicates (K162517) from the same manufacturer for core electrical stimulation and heating features.
- Any differences in technical specifications (e.g., specific pulse width or frequency ranges, output parameters) compared to the other predicate devices are within accepted ranges for TENS/PMS devices and do not raise new questions of safety or effectiveness. This is supported by explanations such as "neither device gives the user control over frequency," "both devices are using standard TENS stimulation frequencies," and the output parameters are "therapeutically effective with either device."
Non-Clinical Testing (Section 8): JKH USA, LLC performed bench tests to ensure the device's design conforms to recognized consensus standards for electrical safety (IEC 60601-1, IEC 60601-2-10), electromagnetic compatibility (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10). Software verification was also conducted per FDA guidance. These tests serve as "proof" that the device is built safely and functions as intended within engineering parameters.

In essence, the "study" proving the device met "acceptance criteria" here is the aggregated body of evidence presented in the 510(k) to demonstrate substantial equivalence to existing, legally marketed devices, rather than a de novo clinical trial with specific performance endpoints.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized depiction of an eagle. The FDA acronym and the full name of the agency are written in blue.

June 21, 2021

JKH USA, LLC Bill Quanqin Dai Manager 1142 S. Diamond Bar Blvd, #861 Diamond Bar, California 91765

Re: K182203

Trade/Device Name: JKH Stimulator Plus Regulation Number: 21 CFR 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT, GZJ, GZI, IPF

Dear Bill Quanqin Dai:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 14, 2019. Specifically, FDA is updating this SE Letter as an administrative correction. FDA has added a new product code, GZI, to better categorize your device technology to be consistent with your 510(k) Summary.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Amber Ballard, OHT5: Office of Neurological and Physical Medicine Devices, by email (Amber.Ballard(@)fda.hhs.gov) or phone (240-402-9983).

Sincerely,

Vivek J. Pinto -S

Vivek Pinto, PhD Division Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

March 14, 2019

JKH USA. LLC Bill Quanqin Dai Manager 1142 S. Diamond Bar Blvd. #861 Diamond Bar, California 91765

Re: K182203

Trade/Device Name: JKH Stimulator Plus Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, NYN, IRT, GZJ, IPF Dated: October 22, 2018 Received: January 2, 2019

Dear Bill Quanqin Dai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K182203

Device Name JKH Stimulator Plus

Indications for Use (Describe) Over-The-Counter Use:

TENS (Modes 1, 2, 4, 5, 6, 8):

PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.

PMS (also called EMS, Modes 1, 3, 7):

PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating: The device of PL-029K13 is intended for temporary relief of minor aches and pains.

Prescription Use:

PL-029K12 and PL-029K13 are intended for the following use:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Relief of pain associated with arthritis
Temporary relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Increase of local blood flow in the treatment area
Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter's Information

Submitter: JKH USA, LLC Mailing Address: 1142 S. Diamond Bar Blvd, #861, Diamond Bar, CA 91765 Contact Person: Dr. Bill Quanqin Dai Tel: 909-929-9896 Email: Bill(@jkhUSA.com Date of Preparation: 06/29/2018

2. Subject Device

Trade/Device Name: JKH Stimulator Plus Common Name: Transcutaneous Electrical Nerve Stimulation (TENS) unit. Powered Muscle Stimulation (PMS) unit, and heating for pain relief, blood circulation, and muscle performance Regulation Medical Specialtv: Neurology Review Panel: Neurology Product Code: NUH, NGX, NYN, GZJ, GZI, IPF, IRT Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter (OTC) and Prescription

3. Predicate device

Predicate Device: Electronic Pulse Stimulator 510(k) Number: K162517 Clearance Date: April 14, 2017 Submitter: JKH Health Co., Ltd.

Predicate Device: Sys*Stim ME 208 510(k) Number: K031017 Clearance Date: May 30, 2003 Submitter: Mettler Electronics Corp.

Predicate Device: ASCEND 510(k) Number: K140333 Clearance Date: July 3, 2014 Submitter: NeuroMetrix, Inc.

Predicate Device: Strive 510(k) Number: K153704 Clearance Date: June 3, 2016 Submitter: DJO, LLC

4. Description of Subject Device

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has multiple program modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 ℃ for temporary relief of minor aches and pains.

The electrodes cleared include the electrode patches/pads and electrode garments, which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.

5. Indications for Use

Over-The-Counter Use:

TENS (Modes 1, 2, 4, 5, 6, 8):

PL-029K12 and PL-029K13 are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The device of PL-029K12 may be used during sleep. The device of PL-029K12 is labeled for use only with its own compatible electrodes.

PMS (also called EMS, Modes 1, 3, 7):

PL-029K12 and PL-029K13 are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating:

The device of PL-029K13 is intended for temporary relief of minor aches and pains.

Prescription Use:

PL-029K12 and PL-029K13 are intended for the following use:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain

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Relief of pain associated with arthritis
Temporary relaxation of muscle spasm
Prevention or retardation of disuse atrophy
Muscle re-education
Maintaining or increasing range of motion
Increase of local blood flow in the treatment area
Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

6. Summary of Substantial Equivalence

The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

	Subject Device	Predicate Device	Predicate Device	Predicate Device	Predicate Device
510(k) Number	K182203	K162517	K031017	K140333	K153704
Submitter/Manufacturer	JKH USA, LLC	JKH Health Co., Ltd.	Mettler ElectronicsCorp.	NeuroMetrix, Inc.	DJO, LLC
Device Name/Model	PL-029K12 andPL-029K13	PL-029K12 andPL-029K13	Sys*Stim ME 208	ASCEND	Strive
Intended Use	Over-The-Counter Use:TENS (Modes 1, 2, 4, 5, 6,8):PL-029K12 and PL-029K13 are used fortemporary relief of painassociated with sore andaching muscles in theshoulder, waist, back, arm,and leg, due to strain fromexercise or normalhousehold and workactivities.PL-029K12 and PL-029K13 are also intendedfor symptomatic relief andmanagement of chronic,intractable pain and reliefof pain associated witharthritis.The device of PL-029K12may be used during sleep.The device of PL-029K12is labeled for use only withits own compatibleelectrodes.PMS (also called EMS,Modes 1, 3, 7):PL-029K12 and PL-029K13 are used tostimulate healthy musclesin order to improve andfacilitate muscleperformance. To be usedfor the improvement of	TENS:To be used fortemporary relief ofpain associated withsore and achingmuscles in theshoulder, waist, back,arm, and leg, due tostrain from exercise ornormal household andwork activities.It is also intended forsymptomatic relief andmanagement ofchronic, intractablepain and relief of painassociated witharthritis.PMS:To stimulate healthymuscles in order toimprove and facilitatemuscle performance.To be used for theimprovement ofmuscle tone andfirmness, and forstrengthening musclesin the arms, abdomen,legs, and buttocks. Notintended for use in anytherapy or for thetreatment of anymedical conditions ordiseases.It is also intended to	1. Symptomatic reliefof chronic intractablepain, acute posttraumatic pain oracute post-surgicalpain2. Temporary relationof muscle spasm3. Prevention ofpostsurgical phlebo-thrombosis throughimmediatestimulation of calfmuscles4. Increasing localblood circulation5. Prevention orretardation of disuseatrophy6. Muscle re-education7. Maintaining orincreasing range ofmotion	ASCEND is intendedfor use as atranscutaneouselectrical nervestimulation device fortemporary relief ofpain associated withsore and achingmuscles in the lowerextremities due tostrain from exerciseor normal householdand work activities.ASCEND is intendedfor use as atranscutaneouselectrical nervestimulation device forthe symptomaticrelief andmanagement ofchronic intractablepain.The device may beused during sleep.The device is labeledfor use only withcompatibleNeuroMetrixelectrodes.	Prescription Use:The StriveTM TENSdevice is used for thesymptomatic reliefand management ofchronic, intractablepain and relief ofpain associated witharthritis. It is alsoused as an adjunctivetreatment for post-surgical and post-trauma acute pain.As a TENS device,indications are for thefollowing conditions:- Symptomatic reliefand management ofchronic, intractablepain- Adjunctivetreatment for post-surgical and post-trauma acute pain- Relief of painassociated witharthritisOver the CounterUse:The StriveTM TENSdevice is used for:-temporary relief ofpain associated withsore and achingmuscles due to strainfrom exercise ornormal household
	muscle tone and firmness,and for strengtheningmuscles in the arms,abdomen, legs, andbuttocks. Not intended foruse in any therapy or for thetreatment of any medicalconditions or diseases.PL-029K12 and PL-029K13 are also intended totemporarily increase localblood circulation in thehealthy muscles of lowerextremities.Heating:The device of PL-029K13is intended for temporaryrelief of minor aches andpains.Prescription Use:PL-029K12 and PL-029K13 are intended for thefollowing use:- Symptomatic relief andmanagement of chronic,intractable pain- Adjunctive treatment forpost-surgical and post-trauma acute pain- Relief of pain associatedwith arthritis- Temporary relaxation ofmuscle spasm- Prevention or retardationof disuse atrophy- Muscle re-education- Maintaining or increasingrange of motion- Increase of local bloodflow in the treatment area- Prevention of post-surgical venous thrombosisthrough immediatestimulation of calf muscles	temporarily increaselocal blood circulationin the healthy musclesof lower extremities.Heating:Temporary relief ofminor aches and pains.			and work activities.-the symptomaticrelief andmanagement ofchronic, intractablepain and relief ofpain associated witharthritis.
Prescription or OTC	OTC and Prescription	OTC	Prescription	OTC	OTC and Prescription
Power Source(s)	Rechargeable or non-rechargeable battery	Rechargeable battery	Main (line) voltage	Rechargeable battery	Rechargeable battery
Compliance withVoluntary Standards?	Yes	Yes	Yes	Yes	Yes
Compliance with 21CFR 898?	Yes	Yes	Yes	Yes	Yes
Functions and design	Electrical stimulation andheat	Electrical stimulationand heat	Electrical stimulation	Electrical stimulation	Electrical stimulation
Maximum skintemperature	43 °C	43 °C	N/A	N/A	N/A
Maximum outputvoltage (Volts +/-20%) at 500Ω	PL-029K12: 57.6PL-029K13: 46.0	PL-029K12: 57.6PL-029K13: 46.0	92	50	30
Maximum outputvoltage (Volts +/-	PL-029K12: 96.0PL-029K13: 90.4	PL-029K12: 96.0PL-029K13: 90.4	144	100	110
20%) at 2KΩ
Maximum output voltage (Volts +/- 20%) at 10kΩ	PL-029K12: 134PL-029K13: 124	PL-029K12: 134PL-029K13: 124	166	100	110
Maximum output current (mA +/- 20%) at 500Ω	PL-029K12: 115.2PL-029K13: 92.0	PL-029K12: 115.2PL-029K13: 92.0	184	100	60
Maximum output current (mA +/- 20%) at 2KΩ	PL-029K12: 48.0PL-029K13: 45.2	PL-029K12: 48.0PL-029K13: 45.2	72	50	55
Maximum output current (mA +/- 20%) at 10KΩ	PL-029K12: 13.4PL-029K13: 12.4	PL-029K12: 13.4PL-029K13: 12.4	17	10	11
Pulse Width (µSec)	PL-029K12: 100PL-029K13: 92	PL-029K12: 100PL-029K13: 92	200	100	70~300
Frequency (Hz)	PL-029K12: 1.2~~156.2PL-029K13: 1.2~~178.5	PL-029K12: 1.2~~156.2PL-029K13: 1.2~~178.5	1~80	60~100	5~122
Maximum Phase charge (µC) at 500Ω	PL-029K12: 23.0PL-029K13: 16.9	PL-029K12: 23.0PL-029K13: 16.9	33.5	10	18
Maximum current density (mA/cm²) at 500Ω	PL-029K12: 3.26PL-029K13: 3.29	PL-029K12: 3.26PL-029K13: 3.29	9.12	0.51	0.33
Maximum average power density (mW/cm²) at 500Ω	PL-029K12: 1.44PL-029K13: 1.26	PL-029K12: 1.44PL-029K13: 1.26	12	3.6	5.53

Table 1. Comparison between the subject device and the predicate device

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7. Substantial Equivalence

As shown in the above comparison Table 1, the subject device submitted is the same as the predicate device in the predicate K162517. While there are no differences between the subject device and the predicate device in K162517, the differences between the subject device and the other predicate devices in K031017, K140333, and K153704 do not raise any new issues of safety or effectiveness, as discussed below.

Both the subject device and the predicate device have the technical specifications that are within the range of other FDA cleared transcutaneous electrical nerve stimulators. For example, in the predicate K153704, the difference of maximum output voltage, maximum output current, maximum current density, and maximum average power density is 40V (110V versus 150V at 10KΩ), 40mA versus 100mA at 500Ω), 10.69 mA/cm² (0.31mA/cm² versus 0.1-11 mA/cm² at 500Ω), and 39.08 mW/cm² (4.92mW/cm² versus 44 mW/cm² at 500Ω), respectively, between the K153704-cleared device and its predicate device. In addition, the output current, phase charge, current density, and average power density are set and delivered at a one-by-one level by the user to a strong but comfortable sensation, so the output voltage, output current, phase charge, and average power density delivered are therapeutically effective with either device. Furthermore, the subject device in this submission and the predicate device in K162517 are exactly the same from the same manufacturer, and have the same maximum output voltage, maximum output current, maximum phase charge, maximum current density, and maximum average power density at 50002, 2KS2, and 10KS2. Therefore, the differences of maximum output voltage, maximum output current, maximum phase charge, maximum current density, and maximum average power density between the subject device and the predicate device does not raise new questions of safety or effectiveness.

The difference of frequencies between the subject device and the predicate device does not raise new types of safety or effectiveness questions because (i) neither device gives the user control over frequency, (ii) both devices are using standard TENS stimulation frequencies, (iii) random frequency stimulation is within the standard practice for TENS devices and is used in the predicate device, and (iv)

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the effectiveness of TENS is not dependent on the use of modulated pulse trains such as those generated by the predicate device, and can be equally achieved through the random frequency stimulation as delivered by the subject device. Similarly, the same case could be seen in the predicate K140333: The K140333-cleared device has a varying frequency between 60 and 100 Hz, while its predicate device cycles through a range of frequencies between 2 and 100 Hz. In addition, in the predicate K140333, the pulse width of the K140333-cleared device is fixed at 100 uSec while that of its predicate device is from 30-220 uSec. The same case applies to the subject device in this submission: the predicate devices are with pulse widths that range from 70-300 uSec, while the subject device has a pulse width of 100 uSec and 92 uSec for the PL-029K13, respectively. Therefore, the difference of pulse width also does not raise new issues of safety or effectiveness.

In addition, the subject device PL-029K13 itself also has a heating mode, and is comparable to the predicate device that could deliver electrical stimulation and heat separately and simultaneously in K162517. The subject device delivers heat through the substantially equivalent technology to the predicate device, and does not raise new concerns of safety or effectiveness.

As demonstrated, there are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications. features, intended use, safety, and effectiveness to the predicate device.

8. Non-Clinical Tests Performed

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
(c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".
(d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".
(e) ISO 10993-10 "Biological evaluation of medical devices Part 10: Tests for Irritation and Skin Sensitization".

In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

The same electrode pads and garments cleared in the predicate K162517 and other biocompatible electrodes described in this submission could apply to the subject device, such as conductive patches/pads, shoes, belts, wraps, sleeves, socks, insoles, gloves, shirts, shorts, and suits, and will not change the safety or effectiveness. Concerns of the safe and proper use of the electrodes have been fully addressed through details in the Labeling.

9. Conclusion

The tests and comparison performed demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the predicate device that has been legally marketed in the United States.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).