POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Device Description

This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.

TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the POCKET TENS (EP-300) device.

Here's the information extracted from the document:

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

The document states that the POCKET TENS (EP-300) device underwent a series of safety and performance tests. It doesn't explicitly list specific quantitative acceptance criteria values next to the device performance for most parameters, but generally states that "All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices."

However, a comparison table (Section 12) between the subject device and two predicate devices provides various specifications. This comparison indirectly implies the acceptance criteria are met if the subject device's specifications are comparable or within acceptable ranges of the predicate devices and comply with relevant standards.

Here's a summary of the stated performance and comparison points, implying acceptance criteria are met by equivalence or compliance:

Acceptance Criteria (Implied)	Reported Device Performance (POCKET TENS (EP-300))
Intended Use	Temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
FDA product code	NUH
Prescription or OTC	OTC (Identical to predicate devices)
Power source(s)	CR2032 Lithium 3V (Identical to Predicate device #2)
Function and design	Electrical stimulation (Identical to predicate devices)
Number of output modes (TENS)	1 (Identical to Predicate device #2)
Number of output channels	Single Channel (Identical to Predicate device #2)
Method of channel isolation	N/A (Identical to Predicate device #2)
Regulated current or regulated voltage	Regulated voltage (Identical to predicate devices)
Software/Firmware/Microprocessor Control?	Yes (Identical to predicate devices)
Automatic overload trip?	Yes (Identical to predicate devices)
Automatic no-load trip?	Yes (Identical to predicate devices)
Automatic shut off?	Yes (Identical to predicate devices)
Patient override control?	Yes (Identical to predicate devices)
Indicator display (On/off status, Low battery, Voltage/current level)	No (Identical to Predicate device #2 for all three)
Timer range (minutes)	20 (Identical to Predicate device #2)
Compliance with voluntary standards	ISO 10993-1, 10993-5, 10993-10, 10993-23, IEC 62304, ISO 14971, ISO TR 24971, IEC 60601-1-2, IEC TR 60601-4-2, ANSI/AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60086-4, IEC 60601-1-6, ANSI/AAMI/IEC 62366-1 (Complies with the latest standards)
Compliance with 21 CFR 898?	Yes (Identical to predicate devices)
Weight	Main device (including a set of pad): 35.6 g; Gel pads (2 pieces): 9.4 g; Battery: 3.0 g
Dimensions	Main device: 66.8 × 35.0 × 10.6 mm; Pad: 99.5 × 62.0 × 1.0 mm; Wire: 391.0 mm
Housing materials and construction	ABS plastic enclosure (Identical to predicate devices)
Waveform	Biphasic, Symmetrical (Identical to Predicate device #1)
Shape	Rectangular (Identical to predicate devices)
Maximum output voltage (@ 500 Ω, 2 kΩ, 10 kΩ)	50V for both phases, peak of 25V for each phase; 92V; 101V (Refer to Section 13 for substantial equivalence)
Maximum output current (@ 500 Ω, 2 kΩ, 10 kΩ)	100mA peak-to-peak, 50mA peak; 37.5mA; 10.1mA (Refer to Section 13 for substantial equivalence)
Pulse Width (μs)	50mA x 0.4mSec = 20 μC (Refer to Section 13 for substantial equivalence)
Frequency (Hz)	4, 6 and 50 (Refer to Section 13 for substantial equivalence)
Net charge (μC per pulse @ 500Ω)	0 (Refer to Section 13 for substantial equivalence)
Maximum phase charge (μC @ 500Ω)	20 (Refer to Section 13 for substantial equivalence)
Maximum average current (mA @ 500Ω)	3.46 (Refer to Section 13 for substantial equivalence)
Electrode conductive surface area (cm²)	31.04 cm² × 2 (=62.08 cm²) (Refer to Section 13 for substantial equivalence)
Maximum current density (mA/cm² @ 500Ω)	1.61080 (Refer to Section 13 for substantial equivalence)
Maximum power density (W/cm² @ 500Ω)	0.0801 (Refer to Section 13 for substantial equivalence)
Burst Mode (Pulse per burst, Burst per second, Burst duration, Duty cycle, Average DC current)	N/A (Identical to Predicate device #1 where applicable, otherwise N/A for those parameters)

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

The document does not explicitly mention a "test set" in the context of clinical data. It states, "No clinical test data was used to support the decision of substantial equivalence."

Instead, the evaluation appears to be based on non-clinical testing, compliance with recognized standards, and comparison with predicate devices. For these non-clinical tests (e.g., biocompatibility, software validation, EMC, electrical safety, performance verification, usability), the sample sizes are not specified, nor is the country of origin or whether they were retrospective or prospective.

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 test data was used and therefore no need for experts to establish ground truth for a clinical test set. The substantial equivalence relies on technical comparison and compliance with standards.

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

Not applicable, as no clinical test data was used and therefore no adjudication was necessary.

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) for pain relief, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable. The device is a physical TENS unit, not an algorithm.

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

Not applicable, as no clinical test data was used. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles outlined in the referenced national and international standards (e.g., ISO, IEC, ANSI/AAMI standards, FDA guidance documents).

8. The sample size for the training set

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2024

Hivox Biotek Inc. Leslie Peng Senior Product Manager 5F., No. 123, Xingde Rd., Sanchong District New Taipei City, 24158 Taiwan

Re: K242815

Trade/Device Name: Pocket Tens (EP-300) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: September 6, 2024 Received: September 18, 2024

Dear Leslie Peng:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a

change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Robert Kang -S

for Pamela Scott, MS 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

Submission Number (if known)

K242815

Device Name

POCKET TENS (EP-300)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

1. Type of Submission Traditional

1. Date of Summary December 16, 2024
HIVOX BIOTEK INC. 3. Submitter Address: 5F., No. 123, Xingde Rd., Sanchong District, New Taipei City 241, Taiwan, R.O.C. Phone: +886-2-8511-2668 Fax: +886-2-8511-2669 Contact: Leslie Peng (leslie.peng@hivox-biotek.com)

4. Identification of the Subject Device

Proprietary name:	POCKET TENS
Model:	EP-300
Regulation number:	21 CFR 882.5890
Regulation description:	Transcutaneous electrical nerve stimulator for pain relief
Product code:	NUH
Device class:	II

5. Identification of the Predicate Device #1

510(k) number:	K171803
Manufacturer:	HIVOX BIOTEK INC.
Proprietary name:	HIVOX OTC Electrical Stimulator
Model:	SEM44-1
Primary Regulationnumber:	21 CFR 882.5890
Primary Regulationdescription:	Transcutaneous electrical nerve stimulator for pain relief
Product code:	NUH, NGX
Device class:	II

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6. Identification of the Predicate Device #2

510(k) number:	K140650
Manufacturer:	HIVOX BIOTEK INC.
Proprietary name:	HIVOX Electric Stimulator OTC TENS, Rapid Relief™Pennypad PP-904
Model:	PP-904
Regulation number:	21 CFR 882.5890
Regulation description:	Transcutaneous electrical nerve stimulator for pain relief
Product code:	NUH
Device class:	II

7. Device Description

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

8. Intended Use / Indications for Use

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9. Substantial Equivalence Comparison

Refer to section 12 for complete comparison table.

10. Non-clinical Testing

A series of safety and performance tests, as follows, were conducted on the subject device in accordance with FDA recognized consensus standards and/or guidance:

Shelf life
Gel pad lifetime
Biocompatibility
- Biological evaluation (ISO 10993-1:2018) -
- -In Vitro Cytotoxicity Test (ISO 10993-5:2009)
- Skin Sensitization Study (ISO 10993-10:2021, ISO 10993-10:2010) |
- -Skin Irritation Study (ISO 10993-23:2021, ISO 10993-10:2010)
Software validation
- IEC 62304:2006+A1:2015 -
- -ISO 14971:2019
- ISO TR 24971:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
EMC and electrical safety ●
- -IEC 60601-1-2:2014+A1:2020
- -IEC TR 60601-4-2:2016
- ANSI/AAMI ES60601-1:2005+A2:2021 -
- IEC 60601-1-11:2015+A1:2020 -
- IEC 60601-2-10:2012+A1:2016 —
- -IEC 60086-4:2019
Performance verification
- Guidance Document for Powered Muscle Stimulator 510(K)s. (June 9, -1999)
Output waveform validation ●
Impedance validation
Usability
- IEC 60601-1-6:2010+A2:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
- ANSI/AAMI/IEC 62366-1:2015+A1:2020 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices.

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11. Clinical Testing

No clinical test data was used to support the decision of substantial equivalence.

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12. Substantial Equivalence Comparison

The subject device, POCKET TENS (EP-300), was compared to the predicate devices in the table below:

Comparison item	Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
510(k) number	K242815	K171803	K140650
Device name	POCKET TENS	HIVOX OTC ElectricalStimulator	HIVOX Electric Stimulator OTCTENS, Rapid Relief™ PennypadPP-904	N/A
Model	EP-300	SEM44-1	PP-904
Manufacturer	HIVOX BIOTEK INC.	HIVOX BIOTEK INC.	HIVOX BIOTEK INC.
Intended Use	POCKET TENS (EP-300)which is home used deviceis designed to be used fortemporary relief of painassociated with sore andaching muscles in theshoulder, back, upperextremities (arm) and lowerextremities (leg) due tostrain from exercise ornormal household work	The device is designed to beused for temporary relief ofpain associated with sore andaching muscles in the shoulder,waist, back, neck, upperextremities (arm), lowerextremities (leg), abdomen andbottom due to strain fromexercise or normal householdwork activities.	The HIVOX Electric StimulatorOTC TENS, Rapid Relief™Pennypad PP-904, is indicated fortemporary relief of pain associatedwith sore and aching muscles inthe upper and lower extremities(arm and/or leg), and lower backdue to strain from exercise ornormal household and workactivities.
Comparison item	Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
	activities.
FDA product code	NUH	NUH, NGX	NUH	All predicates have NUH productcode
Prescription or OTC	OTC	OTC	OTC	Identical to predicate devices
Basic unit characteristics
Power source(s)	CR2032 Lithium 3V	4.5V (batteries, 3x1.5V AAA)	CR2032 Lithium 3V	Identical to Predicate device #2
Function and design	Electrical stimulation	Electrical stimulation	Electrical stimulation	Identical to predicate devices
Number of output modes	TENS:1	TENS:15	TENS:1	Identical to Predicate device #2
Number ofoutputchannels	SynchronousorAlternating?	Single Channel	Two Channels(Synchronous)	Single Channel	Identical to Predicate device #2
	Method ofchannelisolation	N/A	By electrical circuit and software	N/A	Identical to Predicate device #2
Regulated current orregulated voltage?	Regulated voltage	Regulated voltage	Regulated voltage	Identical to predicate devices
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Identical to predicate devices
Automatic overload trip?	Yes	Yes	Yes	Identical to predicate devices
Automatic no-load trip?	Yes	Yes	Yes	Identical to predicate devices
Comparison item	Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
Automatic shut off?	Yes	Yes	Yes	Identical to predicate devices
Patient override control?	Yes	Yes	Yes	Identical to predicate devices
Indicatordisplay	On/offstatus?	No	Yes	No	Identical to Predicate device #2
	Low battery?	No	Yes	No	Identical to Predicate device #2
	Voltage/currentlevel?	No	Yes	No	Identical to Predicate device #2
Timer range (minutes)	20	5-100	20	Identical to Predicate device #2
Comparison item	Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
Compliance withvoluntary standards?	ISO 10993-1:2018ISO 10993-5:2009ISO 10993-10:2010ISO 10993-10:2021ISO 10993-23:2021IEC 62304:2006+A1:2015ISO 14971:2019ISO TR 24971:2020IEC 60601-1-2:2014+A1:2020IEC TR 60601-4-2:2016ANSI/AAMI ES60601-1:2005+A2:2021IEC 60601-1-11:2015+A1:2020IEC 60601-2-10:2012+A1:2016IEC 60086-4:2019IEC 60601-1-6:2010+A2:2020ANSI/AAMI/IEC 62366-1:2015+A1:2020	IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 10993-5/10	IEC/EN 60601-1IEC/EN 60601-1-2IEC/EN 60601-2-10	The subject device complies withthe latest standards.
Compliance with 21 CFR	Yes	Yes	Yes	Identical to predicate devices
Comparison item		Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
898?
Weight		Main device(including a set of pad): 35.6 gGel pads (2 pieces): 9.4 gBattery: 3.0 g	89 g(including belt clip, withoutbatteries),123 g(including belt clip and batteries)	13.7 g (excluded battery)	The differences from weight wouldnot raise concern in safety oreffectiveness as predicate devices
Dimensions[W × H × D]		Approx.Main device:66.8 × 35.0 × 10.6 mmPad: 99.5 × 62.0 × 1.0 mmWire: 391.0 mm	Approx.132 × 63 × 29.5 mm(including belt clip)	Approx.113 × 70 × 10 mm	The differences from dimensionwould not raise concern in safetyor effectiveness as predicatedevices
Housing materials andconstruction		ABS plastic enclosure	ABS Plastic enclosure	ABS Plastic enclosure	Identical to predicate devices
Output specifications
Waveform		Biphasic, Symmetrical	Biphasic, Symmetrical	Monophasic with reversing polarityeach phase	Identical to Predicate device #1
Shape		Rectangular	Rectangular	Rectangular	Identical to predicate devices
Maximumoutput	@ 500 Ω	50V for both phases, peak of25V for each phase	100V peak-to-peak, 50V peak foreach phase	30V peak monophasic	Refer to Section 13 for substantialequivalence
Comparison item	Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
voltage(Vp-p, ±10%)	@ 2 kΩ92@ 10 kΩ101	180250	89.696
Maximumoutputcurrent(mAp-p, ±10%)	@ 500 Ω100mA peak-to-peak, 50mA peak@ 2 kΩ37.5@ 10 kΩ10.1	2009025	60mA peak44.89.6	Refer to Section 13 for substantialequivalence
Pulse Width (μs)	50mA x 0.4mSec = 20 μC	50-450	200	Refer to Section 13 for substantialequivalence
Frequency (Hz)	4, 6 and 50	1-150	2, 5 and 40	Refer to Section 13 for substantialequivalence
Net charge(μC per pulse @ 500Ω)	0	0.001	0.2304	Refer to Section 13 for substantialequivalence
Maximum phase charge(μC @ 500Ω)	20	0.045 = 45 μC	60mA x 0.2mSec = 12 μC	Refer to Section 13 for substantialequivalence
Maximum average current(mA @ 500Ω)	3.46	13.5	2.303	Refer to Section 13 for substantialequivalence
Electrode conductivesurface area (cm²)	$31.04 cm²×2 (=62.08 cm²)$	$20.25 cm²x4 (=81cm²)$	$20.366cm²x2 (=40.732 cm²)$	Refer to Section 13 for substantialequivalence
Comparison item	Subject device	Predicate device #1	Predicate device #2	SubstantialEquivalence Determination
Maximum current density(mA/cm² @ 500Ω)	1.61080	0.667	2.828	Refer to Section 13 for substantialequivalence
Maximum power density(W/cm² @ 500Ω)	0.0801	0.0046	0.163	Refer to Section 13 for substantialequivalence
Burst Mode	Pulse per burst	N/A	3	N/A
	Burst per second	N/A	2/60Hz	N/A
	Burst duration	N/A	36ms	N/A
	Duty cycle	N/A	36/390ms	N/A
Average DC currentthrough electrodes whendevice is on but nopulses are being applied(μA)	0	0	N/A	Identical to Predicate device #1

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13. Similarity and Difference

The subject device and two predicate devices are designed to be used for temporary relief of pain associated with sore, aching muscle. They all fall into the electrical stimulation device category. The application area of the subject device (shoulder, back, upper extremities (arm) and lower extremities (leg)) is within the scope of the predicate device #1 (K171803). Therefore, it acts as the primary predicate device.

The predicate device #2 (K140650) is used to support the demonstration on some technical characteristics and specifications. Although the subject device has slightly different indications for use in comparison to the predicate device #2, the differences do not constitute a new intended use. They still fall into the electrical stimulation device category.

For basic unit characteristics, the subject device has some differences from predicate device #1; however, it is identical to predicate device #2 except for weight and dimensions which will not raise concern in safety or effectiveness.

For output specifications, the subject device is different from predicate devices in some items; however, those parameters are relatively similar and the subject device falls within the parameters of the two predicate devices. As the subject device complies with ANSI/AAMI ES60601-1 and IEC 60601-2-10, which means we have proved its safety as well as the effectiveness comparing with the predicate device. Therefore, the subject device and predicate devices are substantially equivalence on these parameters. The TENS output of the subject device is as safe and effective as the predicate devices.

14. Conclusion

After conducted a series of non-clinical tests to ensure that our design outputs met the specified design inputs and needs of user, we believe that the subject device, POCKET TENS (EP-300), is substantially equivalent to the predicate devices in safety and effectiveness.

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).