Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
Relief of pain associated with arthritis
Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.
Electrical Muscle Stimulation (EMS), used for the following indications:
Temporary relaxation of muscle spasms
Prevent or retard disuse atrophy
Increase of local blood flow in the treatment area
Re-educate muscles
Maintain or increase the range of motion
Prevention of venous thrombosis of the calf muscles immediately after surgery
Program P9 corresponds to EMS mode.

Device Description

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.
The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.
The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.
The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.
The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.
The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for the actiTENS device, primarily focusing on its substantial equivalence to a predicate device (JKH Stimulator Plus - K182203).

Here's the breakdown of the information requested:

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

The document does not explicitly present a "table of acceptance criteria" in the format of a requirement with a corresponding "reported device performance" that unequivocally meets that criterion for clinical efficacy or specific diagnostic accuracy. Instead, it demonstrates substantial equivalence to a predicate device by comparing technological characteristics and performance metrics. The underlying acceptance criterion for this 510(k) submission is that the device is "as safe and effective as the predicate device."

The comparison table (Table 1: Comparison of actiTENS with JKH Stimulator Plus (K182203) and Table 2: Comparison of actiTENS with JKH Stimulator Plus (K182203) with regards to TENS and EMS performance) serves as the primary evidence. Here's a summary derived from those tables and surrounding text:

Acceptance Criterion (Implicitly based on Predicate)	Reported actiTENS Performance
Indications for Use (TENS)	Symptomatic relief and management of chronic, intractable pain; Adjunctive treatment for post-surgical and post-trauma acute pain; Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; Relief of pain associated with arthritis. Programs P1-P8, P10-P13.
Indications for Use (EMS)	Temporary relaxation of muscle spasms; Prevent or retard disuse atrophy; Increase of local blood flow in the treatment area; Re-educate muscles; Maintain or increase the range of motion; Prevention of venous thrombosis of the calf muscles immediately after surgery. Program P9.
Prescription or OTC Use	Prescription only. (Predicate was OTC and Prescription. This is noted as eliminating risks associated with OTC use.)
Power Source	Rechargeable (lithium-ion battery). (Predicate was rechargeable or non-rechargeable. Noted as not introducing new risks.)
Functions and Design	Electrical stimulation only. (Predicate included electrical stimulation and heat. This is noted as eliminating risks associated with the heat function.)
Maximum Output Voltage (Volts +/- 20%) at 500Ω	Ranges from 29.1V (P10) to 30.2V (multiple programs). (Compared to predicate's 30.2V to 57.6V. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
Maximum Output Voltage (Volts +/- 20%) at 2KΩ	57.9V (all programs). (Compared to predicate's 57.9V to 96.0V. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
Maximum Output Voltage (Volts +/- 20%) at 10KΩ	N/A (Device stops delivering current at this impedance for safety). (Compared to predicate's 124V-134V. Noted as a safety feature that prevents measurements at this impedance).
Maximum Output Current (mA +/- 20%) at 500Ω	Ranges from 58.2mA (P10) to 60.4mA (multiple programs). (Compared to predicate's 60.4mA to 115.2mA. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
Maximum Output Current (mA +/- 20%) at 2KΩ	28.95mA (all programs). (Compared to predicate's 28.95mA to 48.0mA. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
Maximum Output Current (mA +/- 20%) at 10KΩ	N/A (Device stops delivering current at this impedance for safety). (Compared to predicate's 12.4mA-13.4mA. Noted as a safety feature that prevents measurements at this impedance).
Pulse Width (µSec)	Ranges from 57.5µSec (P12) to 247.5µSec (P3, P9). (Compared to predicate's 92µSec-100µSec. Noted as not raising new safety/effectiveness questions.)
Frequency (Hz)	Ranges from 2Hz (P3, P6, P8 modulated) to 100Hz (P1, P4, P5, P7, P6). (Compared to predicate's 156.2Hz-178.5Hz. Noted as in range or below predicate, not raising new safety/effectiveness questions.)
Maximum Phase Charge (µC) at 500Ω	Ranges from 3.5µC (P12) to 14.9µC (P3). (Compared to predicate's 16.9µC-23.0µC. Noted as in the same range or lower than predicate, not raising new safety/effectiveness questions.)
Maximum Current Density (mA/cm²) at 500Ω	Ranges from 1.7mA/cm² (P8) to 3.0mA/cm² (multiple programs). (Compared to predicate's 3.26mA/cm²-3.29mA/cm². Noted as in the same range or higher but within limits, not raising new safety/effectiveness questions, specifically <250mW/cm² for power density.)
Maximum Average Power Density (mW/cm²) at 500Ω	Not explicitly listed, but inferred to be within limits from current density discussion (<250mW/cm² as required by guidance for Powered Muscle Stimulator).
Compliance with Voluntary Standards	Yes (Same as predicate)
Compliance with 21 CFR 898	Yes (Same as predicate)
Electrical Safety and EMC	Met IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10.
Software Verification and Validation	Met IEC 62304 and FDA guidance documents.
Biocompatibility	Electrodes previously cleared under K070807.
Shelf-life	Electrodes cleared under K070807, battery 12 months (information from manufacturer).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Human Clinical Performance Testing: Clinical testing was not required to demonstrate the safety and effectiveness of the device." Therefore, there is no test set of clinical data from human subjects in the traditional sense for evaluating device performance. The performance data presented are primarily from benchtop testing and comparisons to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical human performance testing was conducted that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical human performance testing was conducted that would require adjudication.

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

Not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS), not an AI-assisted diagnostic or imaging device that would involve human readers or MRMC studies.

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

This concept is not directly applicable to a TENS/EMS device. The "standalone" performance is assessed through the electrical safety, EMC, software, and benchtop performance testing, which evaluate the device's technical specifications.

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

For the safety and performance evaluation, the "ground truth" is established through:

Engineering specifications and standards: IEC 60601-1 series, IEC 62304, ASTM D4169-16, UL 1642, IEC 62366-1, IEC 62133-2.
Comparison to a legally marketed predicate device: The characteristics and demonstrated safety/effectiveness of the JKH Stimulator Plus (K182203) serve as a benchmark.
Manufacturer's data: For components like battery shelf-life.

8. The sample size for the training set

Not applicable, as this device does not utilize a "training set" for an algorithm in the way AI/Machine Learning models do.

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

Not applicable.

Summary

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December 22, 2020

Sublimed % Robert Packard President Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738

Re: K202159

Trade/Device Name: actiTENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ, NGX, NYN, IPF Dated: July 30, 2020 Received: August 3, 2020

Dear Robert Packard:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Amber Ballard, PhD Assistant 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

Enclosure

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Indications for Use

510(k) Number (if known) K202159

Device Name actiTENS

Indications for Use (Describe)

actiTENS is intended to be used as:

· Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:
Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
Relief of pain associated with arthritis

Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.

· Electrical Muscle Stimulation (EMS), used for the following indications:

Temporary relaxation of muscle spasms
Prevent or retard disuse atrophy
Increase of local blood flow in the treatment area
Re-educate muscles
Maintain or increase the range of motion
Prevention of venous thrombosis of the calf muscles immediately after surgery

Program P9 corresponds to EMS mode.

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)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

-SUBMITTER SUBLIMED 137 rue de Mayoussard Moirans, F-38430 France Tel: +33(0)4-76-93-37-15
Contact Person: Corinne Bulteau Date Prepared: December 22, 2020

II. DEVICE
Trade/Device Name:	actiTENS
Classification Name:	Transcutaneous Electrical Nerve Stimulator for Pain Relief
Regulation:	21 CFR § 882.5890
Regulatory Class:	Class II
Product Classification Code:	GZJ, NGX, NYN, IPF

III. PREDICATE DEVICE
Predicate Manufacturer:	JKH USA, LLC
Predicate Trade Name:	JKH Stimulator Plus
Predicate 510(k):	K182203

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

actiTENS is a transcutaneous electrical nerve stimulation (TENS) medical device designed to manage chronic pain in people ages 22 and older.

The compact design and flexible shape of the actiTENS electrical impulse generator allows to fix it for daily use directly to the body of the patient.

The impulse generator is delivered with a separate cradle which allows safely recharging its nonremovable battery.

The actiTENS is compatible with a selection of disposable electrodes and compatible connector cables transmit the electrical stimulation impulses to the targeted nerves according to the selected therapy. The electrical stimulation waveforms are biphasic and asymmetric.

The actiTENS is controlled via a downloadable mobile app for iPhone which allows the comfortable and simple selection of the adequate stimulation program.

The actiTENS is intended to be used by the patient at home and also for therapeutic application by medical professionals.

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It is available for prescription only.

V. INDICATIONS FOR USE

actiTENS is intended to be used as:

· Transcutaneous Electrical Nerve Stimulator (TENS), used for the following indications:

Symptomatic relief and management of chronic, intractable pain
Adjunctive treatment for post-surgical and post-trauma acute pain
Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities
Relief of pain associated with arthritis

Programs P1, P2, P3, P4, P5, P6, P7, P8, P10, P11, P12 and P13 correspond to TENS mode.

· Electrical Muscle Stimulation (EMS), used for the following indications:

Temporary relaxation of muscle spasms
Prevent or retard disuse atrophy
Increase of local blood flow in the treatment area
Re-educate muscles
Maintain or increase the range of motion
Prevention of venous thrombosis of the calf muscles immediately after surgery

Program P9 corresponds to EMS mode.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVCE

The table below provides a comparison of indications for use and technological characteristics between the subject device and the predicate device in order to demonstrate substantial equivalence:

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Comparison with Predicate Device:

Table 1: Comparison of actiTENS with JKH Stimulator Plus (K182203).

Feature	actiTENS	JKH Stimulator Plus -K182203	Comparison
Indications for Use	actiTENS is intended to beused as:• Transcutaneous ElectricalNerve Stimulator (TENS),used for the followingindications:- Symptomatic relief andmanagement of chronic,intractable pain- Adjunctive treatment forpost-surgical and post-traumaacute pain- Temporary relief of painassociated with sore andaching muscles due to strainfrom exercise or normalhousehold and work activities- Relief of pain associatedwith arthritisPrograms P1, P2, P3, P4, P5,P6, P7, P8, P10, P11, P12 andP13 correspond to TENSmode.• Electrical MuscleStimulation (EMS), used forthe following indications:	Over-the-Counter Use:TENS (Modes 1, 2, 4, 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 normal householdwork activities. PL-0219K12and PL-029K13 are also intendedfor symptomatic relief anmanagement of chronic,intractable pain and relief ofpain associated witharthritis.The device of PL-029K12may be used during sleep.The device of PL-029K12 islabeled for use only with itsown compatible electrodes.PMS (also called EMS,Modes 1, 3, 7):PL-029K12 and PL-	The subject device is notintended for OTC use, andthe prescription use of thesubject device is identical tothe indications of thepredicate model PL-029K12.

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- Temporary relaxation ofmuscle spasms	029K13 are also intended totemporarily increase localblood circulation in thehealthy muscles of lowerextremities.
- Prevent or retard disuseatrophy	Heating:The device of PL-029K13is intended for temporaryrelief of minor aches andpains.
- Increase of local blood flowin the treatment area	Prescription Use:PL-029K12 and PL-029K13 are intended forthe following use:
- Re-educate muscles	-Symptomatic relief andmanagement of chronic,interactable pain
- Maintain or increase therange of motion	-Adjunctive treatment forpost-surgical and post-trauma acute pain
- Prevention of venousthrombosis of the calfmuscles immediately aftersurgery	-Relief of pain associatedwith arthritis
Program P9 corresponds toEMS mode.	-Temporary relaxation ofmuscle spasm
	-Prevention or retardation ofdisuse atrophy
	-Muscle re-education
	-Maintaining or increasingrange of motion
	-Increase of local bloodflow in the treatment area
	-Prevention of post-surgical venousthrombosis through

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		immediate stimulation ofcalf muscles
Prescription or OTC	Prescription	OTC and Prescription	The subject device does notinclude OTC indications,but this eliminates the risksassociated with OTC use.
Power Source(s)	Rechargeable	Rechargeable or non-rechargeable battery	The subject device islimited to use with therechargeable lithium-ionbattery, but this does notintroduce any new risks.
Compliance with VoluntaryStandards?	Yes	Yes	Same
Compliance With 21 CFR898?	Yes	Yes	Same
Functions and design	Electrical stimulation	Electrical stimulation andheat	The subject device does notinclude the IRT productclassification, and thiseliminates the risksassociated with thatfunction.
Maximum skin temperature	N/A	43°C	The subject device does notinclude the IRT productclassification and does notprovide heat

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		actiTENS	JKH Stimulator Plus – K182203	Comparison
Maximum outputvoltage (Volts+/- 20%) at500Ω	P1		30.2 PL- 029K12: 57.6	Maximum output voltage of the subjectdevice is in the range or below this of thepredicate device. These technologicaldifferences between the subject andpredicate device do not raise new safetyand effectiveness questions
	P2		30.2 PL- 029K13: 46.0
	P3		30
	P4		30.2
	P5		30.2
	P6		30
	P7		30.2
	P8		30.2
	P9		29.5
	P10		29.1
	P11		29.3
	P12		30.2
	P13		30.2
Maximum outputvoltage (Volts+/- 20%) at2KΩ	P1		57.9 PL- 029K12: 96.0	Maximum output voltage of the subjectdevice is in the range or below this of thepredicate device. These technologicaldifferences between the subject andpredicate device do not raise new safetyand effectiveness questions
	P2		57.9 PL- 029K13: 90.4
	P3		57.9
	P4		57.9
	P5		57.9
	P6		57.9
	P7		57.9
	P8		57.9
	P9		57.9
	P10		57.9
	P11		57.9
	P12		57.9
	P13		57.9
Maximum outputvoltage (Volts+/- 20%) at$10KΩ$	P1P2P3P4P5P6P7P8P9P10P11P12P13	N/A	PL-029K12: 134PL-029K13: 124	The EIG monitors the impedance of eachchannel and stop any running program (orrefuse to launch one) if the measuredimpedance is out of a specified range. Thisfeature ensures a proper installation of theEIG, the cables and electrodes. If anelectrode peels off, stopping the stimulationprogram quickly enough prevents thepatient from feeling an electric discharge asthe attached surface diminishes. The 10$kOhm$ is at the upper range and the EIGrefused to launch a stimulation program,thus the measurement could not beperformed
Maximum outputcurrent(mA+/- 20%) at$500Ω$	P1P2P3P4P5P6P7P8P9P10P11P12P13	60.460.46060.460.46060.460.45958.258.660.460.4	60.4 PL-029K12: 115.260.4 PL-029K13: 92.0	Maximum output current of the subjectdevice is in the range or below this of thepredicate device. These technologicaldifferences between the subject andpredicate device do not raise new safetyand effectiveness questions
Maximum outputcurrent(mA+/- 20%) at2KΩ	P1	28.95	PL-029K12: 48.0	Maximum output current of the subjectdevice is in the range or below this of thepredicate device. These technologicaldifferences between the subject andpredicate device do not raise new safetyand effectiveness questions
	P2	28.95	PL-029K13: 45.2
	P3	28.95
	P4	28.95
	P5	28.95
	P6	28.95
	P7	28.95
	P8	28.95
	P9	28.95
	P10	28.95
	P11	28.95
	P12	28.95
	P13	28.95
Maximum outputcurrent(mA+/- 20%) at10kΩ	P1	N/A	PL-029K12: 13.4	The EIG monitors the impedanceof eachchannel and stop any running program (orrefuse to launch one) if the measuredimpedance is out of a specified range. Thisfeature ensures a proper installation of theEIG, the cables and electrodes. If anelectrode peels off, stopping the stimulationprogram quickly enough prevents thepatient from feeling an electric discharge asthe attached surface diminishes. The 10kOhm is at the upper range and the EIGrefused to launch a stimulation program,thus the measurement could not beperformed
	P2		PL- 029K13: 12.4
	P3
	P4
	P5
	P6
	P7
	P8
	P9
	P10
	P11
	P12
	P13
	P1	197.5
Pulse Width (µSec)	P2	147 PL-029K12: 100		These technological differences betweenthe subject and predicate device do notraise new safety and effectivenessquestions
	P3	247.5 PL-029K13: 92
	P4	197.5
	P5	147.5
	P6	200 or 147
	P7	147.5
	P8	modulated 100-200
	P9	247.5
	P10	147.5
	P11	147.5
	P12	57.5
	P13	177.5

Frequency (Hz)	P1	100 PL-029K12: 156.2		Frequencies of the subject device is in therange or below this of the predicatedevice. These technological differencesbetween the subject and predicate devicedo not raise new safety and effectivenessquestions
	P2	80 PL-029K13: 178.5
	P3	2
	P4	100
	P5	100
	P6	2 or 100
	P7	100
	P8	modulated 2-80
	P9	50
	P10	80
	P11	80
	P12	80
	P13	10

Table 2: Comparison of actiTENS with JKH Stimulator Plus (K182203) with regards to TENS and EMS performance.

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Maximum Phasecharge (µC) at 500Ω
Maximum Phasecharge (µC) at 500Ω	P1	11.9	PL-029K12: 23.0	The maximum phase charge is in the samerange than the maximum phase charge ofthe predicate. Furthermore the highestvalue for the predicate is over than theintended device. This raises no new safetyor effectiveness questions.
	P2	8.9	PL-029K13: 16.9
	P3	14.9
	P4	11.9
	P5	8.9
	P6	12.0
	P7	8.9
	P8	12.1
	P9	14.6
	P10	8.6
	P11	8.6
	P12	3.5
	P13	10.7
Maximum currentdensity (mA/cm2) at500Ω	P1	3.0	PL-029K12: 3.26	The maximum current density is in thesame range than the maximum currentdensity of the predicate. Furthermore thehighest value for the predicate is over thanthe intended device. This raises no newsafety or effectiveness questions.
	P2	3.0	PL-029K13: 3.29
	P3	3.0
	P4	3.0
	P5	3.0
	P6	3.0
	P7	3.0
	P8	1.7
	P9	2.9
	P10	2.9
	P11	2.9
	P12	3.0
	P13	3.0

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The subject device and predicate device have equivalent indications for use and technological characteristics, with the exception that the subject device does not include over-the-counter-use (NUH product classification) and the subject device does not include heat as a modality (IRT product classification).

The predicate device claims two main functions: electrical stimulation and heat. The predicate device modalities work independently. Each modality has its own independent therapeutic effect. The subject device claims only the electrical stimulation effect as many devices cleared by the FDA, while the heating modality is exempt from 510(k) clearance. This technological difference between the subject and predicate device does not raise new safety and effectiveness questions. Concerning the maximum output voltage and the maximum output current, the subject device has been developed as a current generator with a maximum setpoint current of 60mA and has been limited by hardware to deliver output voltage of 60V. Thus it delivers a current of 60mA at 60V for 1KΩ. Above this charge the maximum output power will decrease. In each case the maximum output current and maximum output voltage are lower than the predicate. The subject device presents a maximum phase charge lower than the predicate device. In addition, the output voltage, phase charge, current density and average power density depends on the output current that is set by the user. The output current always starts at 0mA and is increased manually by the user with a 0.5mA increment, to achieve a strong but comfortable sensation, so the output voltage, output current, phase charge, current density and average power density delivered are therapeutically effective with the subject device. These technological differences between the subject and predicate device do not raise new safety and effectiveness questions.

Maximum output current and maximum output voltage at 10k Ω are not defined in the subject device because 10k Ω is the upper limit of the range of charge at which the subject device stops delivering currents. For the comfort and safety of the patient a limited range of charge has been defined in the subject device, to forbid electric current generation in case of short circuit or if an electrode is peeling off of the patient skin.

The difference of frequencies and pulse width between the subject device and predicate device does not raise new types of safety or effectiveness questions because the user chooses the frequency and the pulse width through different kind of programs using the mobile application and programs are using standard TENS stimulation frequencies and pulse width. The maximum current density and maximum average power density are directly linked to the pads surfaces used with the device. The only recommended pads with the subject device are 4.5cmX4.5cm then the density is calculating using the voltage and current generator capacities. The subject device presents maximum current density and maximum average power density higher than the predicate but the maximum power density is less than 250 mW/cm² as required by the guidance for Powered Muscle Stimulator the maximum power density is also less than 250 mW/cm². These technological differences between the subject and predicate device do not raise new safety and effectiveness questions.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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Sterilization

N/A - Device is non-sterile.

Shelf-life Testing

The electrodes are already cleared under K070807, and shelf-life testing for the electrodes is provided in that submission.

The battery is the only component that is likely to be impacted by time-dependent product degradation for the controller. The balance of the hardware is not expected to be negatively impacted by time-dependent product degradation.

Information regarding the battery shelf-life was provided by the battery manufacturer and the battery shelf-life is 12 months.

Biocompatibility Testing

Biocompatibility of the electrodes was provided in a previous 510(k) submission (K070807).

Electrical safety and electromagnetic compatibility (EMC)

The following electrical safety and EMC testing reports were provided:

Electrical Safety Testing IEC 60601-1, plus national deviations to address the differences . between IEC 60601-1:2005 and ANSI AAMI ES 60601-1:2005/(R)2012 and A1:2012
EMC Testing IEC 60601-1-2
Usability IEC 60601-1-6 ●
Home Use Environment IEC 60601-1-11 ●
. Nerve and Muscle Stimulators IEC 60601-2-10

Software Verification and Validation Testing

Software verification and validation testing was provided in accordance with IEC 62304 and FDA guidance documents.

Benchtop Performance Testing

The following benchtop performance testing was provided:

Transportation Testing ASTM D4169-16 ●
Lithium Battery UL 1642 ●
Usability IEC 62366-1 ●
Lithium Battery IEC 62133-2 .

Animal Performance Testing

Animal performance testing was not required to demonstrate safety and effectiveness of the

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device.

Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

VIII. CONCLUSIONS

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).