To be 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.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 2, 3, 4 and 5)

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.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Device Description

The Electrical Stimulator System delivers electric pulses to the user's body areas such as the back, neck, and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, including transcutaneous electrical nerve stimulation (TENS) and power muscle stimulation (PMS) that is also called Electrical Muscle Stimulation (EMS). It includes the operating elements of an ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and can be attached and detached to electrodes.

The electrodes cleared include the electrode pads and electrode garments, which may be packaged separately and/or together with the subject device.

The associated accessories include: Arm Pad ( 34x56mm±2mmx2 ) * 1 Abdominal Pad(34x56mm±2mmx6) * 1 Gel Pad ( 34x56mm±2mm,produced by GMDASZ with K092546) * 8 USB Cable * 1 Operating Instruction * 1

AI/ML Overview

The provided document is a 510(k) summary for an Electrical Stimulator System (K192201). It outlines the comparison of the proposed device to a predicate device and details the non-clinical tests performed to demonstrate substantial equivalence.

Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are primarily based on demonstrating substantial equivalence to the predicate device (Electronic Pulse Stimulator, K153520) through compliance with recognized standards and comparable technical characteristics. The reported device performance is presented as its adherence to these standards and measurements of its electrical characteristics.

Here's a table summarizing the implicit acceptance criteria based on substantial equivalence and the reported performance:

Acceptance Criteria Category	Specific Criteria (Implicitly met by SE claim and standards conformance)	Reported Device Performance (as stated or implied)
General	Substantial Equivalence (SE) to Predicate Device (K153520)	Judged as "SE" for all categories where direct comparison was possible or "Similar" with justification for differences.
Technological Characteristics	Similar Company Name, Device Name, Classification, Regulation, Class, Prescription/OTC, Functions & Design, Power Source.	All explicitly "SE" to predicate (e.g., NUH, 21 CFR 882.5890, Class II, OTC, Electrical stimulation, Rechargeable battery).
Intended Use	Similar Indications for Use for TENS and PMS modes.	Indications explicitly stated and compared, judged as "SE". While mode numbers differ (e.g., TENS Modes 1&6 vs Predicate's 1,2,4,5,6), the fundamental TENS and PMS applications are the same.
Safety Factor & Performance	Conformance with IEC 60601-1 (Electrical Safety)	Explicitly states "Conformance with IEC 60601-1"
	Conformance with IEC 60601-1-2 (EMC)	Explicitly states "Conformance with IEC 60601-1-2"
	Conformance with ISO 10993-1 (Biocompatibility)	Explicitly states "Conformance with ISO 10993-1"
	Conformance with IEC 60601-2-10 (Performance for nerve/muscle stimulators)	Explicitly states "Conformance with IEC 60601-2-10:2012"
	Similar Waveform (Biphasic, symmetrical)	Explicitly states "Biphasic, symmetrical", judged "SE".
	Acceptable Pulse Width (within safety range)	Range 300µs - 100µs - 300µs. Judged "Similar" with justification that differences are safe.
	Acceptable Maximum Output Voltage (at 500Ω, 2KΩ, 10KΩ)	Provided values for modes 1-6. Judged "Similar" with justification that differences are safe.
	Acceptable Maximum Output Current (at 500Ω, 2KΩ, 10KΩ)	Provided values for modes 1-6. Judged "Similar" with justification that differences are safe.
	Acceptable Pulse Period (within safety range)	Range 20~500 mSec. Judged "Similar" with justification that differences are safe.
	Acceptable Frequency (within safety range)	Mode-specific frequencies (e.g., Mode 1: 5Hz, Mode 5: 10~50Hz). Judged "Similar" with justification that differences are safe.
	Acceptable Maximum Phase Charge (at 500Ω)	Provided values for modes 1-6. Judged "Similar" with justification that differences are safe.
	Acceptable Maximum Charge Density (mA/cm²) (at 500Ω)	Provided values for modes 1-6 per arm/abs. Judged "Similar" with justification that differences are safe.
	Acceptable Maximum Average Power Density (mW/cm²) (at 500Ω)	Provided values for modes 1-6 per arm/abs. Judged "Similar" with justification that differences are safe.
Software Verification	Software V&V according to FDA guidance (Moderate Level of Concern)	"Software verification and validation testing were conducted and documentation was provided... The software for this device was considered as a 'Moderate' level of concern."
Basic Unit Characteristics	Similar physical and functional characteristics to predicate device.	Table 2 (not provided in text) would detail these. Implicitly judged "SE".

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This means there was no "test set" in the sense of a clinical patient cohort. The tests performed were bench tests and non-clinical tests to verify that the proposed device met design specifications and was substantially equivalent to the predicate.

Sample size: Not applicable in the context of human subjects or a clinical test set. For bench testing, sample size would refer to the number of units tested, which is not specified but would typically be a small number of devices to demonstrate consistent performance.
Data Provenance: The tests were "bench tests" performed by the manufacturer (Gymmax Technology Shenzhen Co., Ltd. in PEOPLE'S REPUBLIC OF CHINA). The data is therefore from laboratory/engineering testing, not clinical data, and is retrospective for the purpose of the 510(k) submission.

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

Not applicable. As noted above, there was no clinical test set using human subjects to determine "ground truth" for clinical performance. The "ground truth" for substantial equivalence was established by demonstrating compliance with recognized standards and comparing technical specifications to the predicate device. This typically involves engineers and quality assurance professionals with expertise in medical device testing and regulatory compliance.

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

Not applicable, as there was no clinical test set requiring human expert adjudication of results.

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. This device is an electrical stimulator, not an imaging analysis AI device. No MRMC study was conducted.

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

Not applicable. This device is not an algorithm for diagnostic interpretation. Its "performance" is its electrical output and safety, which was assessed in bench tests, effectively in a "standalone" manner (device operating alone without a human interpreting its output for diagnostic purposes).

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

The "ground truth" for this submission is based on:

Compliance with recognized industry standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993 series.
Comparison to the predicate device's established safe and effective performance: The predicate device (K153520) serves as the benchmark for "substantial equivalence."
Safety calculations and engineering analysis: Justification provided for differences in pulse width, maximum phase charge, and frequency range relies on calculations demonstrating continued safety within acceptable limits.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its design and performance are based on electro-mechanical principles and engineering, not machine learning.

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

Not applicable, for the same reason as point 8.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 12, 2020

Electronic Pulse Stimulator % Salon Chen System engineer IMD Medical & Drug technology service institutions Tianbao Office Room 225, Sha Tai Road No.209 Shenzhen city, 518117 Cn

Re: K192201

Trade/Device Name: Electrical Stimulator System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH. NGX. NYN Dated: June 8, 2020 Received: June 8, 2020

Dear Salon Chen:

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,

Vivek Pinto, PhD 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) K192201

Device Name

Electrical Stimulator System

Indications for Use (Describe)

TENS (Modes 1 and 6)

To be 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.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 2, 3, 4 and 5)

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

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

Submitter's Identification: 1.

Company Name: Gymmax Technology Shenzhen Co., Ltd.
Establishment Registration Number: 3007689716
Address: East 5F, A2 Building, Huimingsheng DingFeng Technology Park, Fuhai Street, Fuyong Town, Baoan District, 518103 Shenzhen, PEOPLE'S REPUBLIC OF CHINA
Phone:+86-755-2912-4050
Fax: +86-755-2912-4050
Contact Person(Title):Benson Wang (General Manager)
E-mail: benson_gmx@qq.com
Date of Preparation: June,01,2020

2. Name of the Device:

A Electrical Stimulator System
Models: GME-SS-001、GMT-SS-001、GMM-SS-001

3. Common Name and Classification:

Stimulator, Nerve, Transcutaneous, Over-The-Counter
Classification Product Code: NUH,NGX and NYN
Regulation Number:21 CFR 882.5890
Class: Il

4. Predicate Device Information:

510(k) Number: K153520
Predicate Device Name: Electronic Pulse Stimulator
Manufacturer: JKH Health Co., Ltd
This predicate has not been subject to a design-related recall

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A No reference devices were used in this submission.

Application Correspondent 5.

Company Name: IMD Medical & Drug technology service institutions
Phone: +86-18613190779
Fax: +86-755-62809168
Contact Person(Title):Salon Chen (System engineer)
E-mail: 33999439@qq.com

Device Description 6.

The electrodes cleared include the electrode pads and electrode garments, which may be packaged separately and/or together with the subject device.

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7. Indications for Use

TENS (Modes 1 and 6)

To be 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.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 2, 3, 4 and 5)

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

8. Comparison to the predicate device

Electrical stimulation is the technological principle for both the subject and predicate device. In the EMS modes, electronic pulses are sent through electrode pads to passively exercise the affected muscle. When your muscle receives this signal, it contracts and flexes naturally, as it would during physical exercise. And like with physical exercise, when the pulse ceases, the muscle relaxes and the cycle can start over again. In the TENS modes, the gentle electrical pulses were sent through electrode pads and into skin to block or shut out the pain message from ever reaching the brain from the source of the pain.

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Table 1: Technological Characteristics

Elements ofComparison	Proposed Device	Predicate Device	Judgment
CompanyName	Gymmax Technology Shenzhen Co.,Ltd.	JKH Health Co., Ltd	/
Device Name	Electrical Stimulator System	Electronic Pulse Stimulator	/
ClassificationProduct Code	NUH	NUH	SE
SubsequentProduct Codes	NGX, NYN	NGX, NYN	SE
Regulation	21 CFR 882.5890	21 CFR 882.5890	SE
ClassificationName	Transcutaneous electrical nervestimulator for pain relief	Transcutaneous electrical nervestimulator for pain relief	SE
Class	2	2	SE
Prescription or OTC	OTC	OTC	SE
Functions anddesign	Electrical stimulation	Electrical stimulation	SE
PowerSource(s)	Rechargeable battery	Rechargeable battery	SE
	TENS (Modes 1and 6)	TENS (Modes 1, 2, 4, 5, 6)
Intended Use	To be used for temporary relief ofpain associated with sore and achingmuscles in the shoulder, waist, back,arm, and leg, due to strain fromexercise or normal household andwork activities.It is also intended for symptomaticrelief and management of chronic,intractable pain and relief of painassociated with arthritis.PMS (Modes 2,3,4,5)To stimulate healthy muscles in orderto improve and facilitate muscleperformance. To be used for theimprovement of muscle tone andfirmness, and for strengtheningmuscles in the arms, abdomen, legs,and buttocks. Not intended for use inany therapy or for the treatment ofany medical conditions or diseases.It is also intended to temporarilyincrease local blood circulation in thehealthy muscles of lower extremities.	To be used for temporary relief ofpain associated with sore andaching muscles in the shoulder,waist, back, arm, and leg, due tostrain from exercise or normalhousehold and work activities.It is also intended for symptomaticrelief and management of chronic,intractable pain and relief of painassociated with arthritis.PMS (Modes 1 and 3)To stimulate healthy muscles in orderto improve and facilitate muscleperformance. To be used for theimprovement of muscle tone andfirmness, and for strengtheningmuscles in the arms, abdomen,legs, and buttocks. Not intended foruse in any therapy or for thetreatment of any medical conditionsor diseases.It is also intended to temporarilyincrease local blood circulation inthe healthy muscles of lowerextremities.	SE
Safety factor &Performance	Proposed Device	Predicate Device	Judgment
Electrical Safety	Conformance with IEC 60601-1	Conformance with IEC 60601-1	SE
EMC	Conformance with IEC 60601-1-2	Conformance with IEC 60601-1-2	SE
Biocompatiblity	Conformance with ISO 10993-1	Conformance with ISO 10993-1	SE
Performance	Conformance with IEC60601-2-10:2012 medical electricalequipment - part 2-1	Conformance with IEC60601-2-10:2012 medical electricalequipment - part 2-1	SE
Waveform	Biphasic, symmetrical	Biphasic, symmetrical	SE
Pulse width	300µs-100µs -300µsImage: Pulse width for proposed device	100µs -100µs -100µsImage: Pulse width for predicate device	Similar(Note 1)
Maximumoutput voltage(volts+/-20%) at500Ω	Mode 1: 46Mode 2: 43.2Mode 3: 29.2Mode 4: 29.2Mode 5: 44Mode 6: 29.2	Mode 1: This mode cyclesthe following modesMode 2: 39.2Mode 3: 64Mode 4: 56.8Mode 5: 33.2Mode 6: 31.6	Similar(Note 1)
Maximumoutput voltage(volts+/-20%) at2KΩ	Mode 1: 75Mode 2: 80Mode 3: 64Mode 4: 63Mode 5: 82Mode 6: 64	Mode 1: This mode cyclesthe following modesMode 2: 82.4Mode 3: 84Mode 4: 79.2Mode 5: 70.4Mode 6: 67.2	Similar(Note 1)
Maximumoutput voltage(volts+/-20%) at10KΩ	Mode 1: 90Mode 2: 90Mode 3: 86Mode 4: 90Mode 5: 90Mode 6: 90	Mode 1: This mode cyclesthe following modesMode 2: 129Mode 3: 120Mode 4: 84.8Mode 5: 121Mode 6: 124	Similar(Note 1)
Maximumoutput current(mA+/-20%) at500Ω	Mode 1: 92Mode 2: 86.4Mode 3: 58.4Mode 4: 58.4Mode 5: 88Mode 6: 58.4	Mode 1: This mode cyclesthe following modesMode 2: 78.4Mode 3: 128Mode 4: 113.6Mode 5: 64.4Mode 6: 63.2	Similar(Note 1)
Maximumoutput current(mA+/-20%) at2KΩ	Mode 1: 37.5Mode 2: 40Mode 3: 64Mode 4: 31.5Mode 5: 41Mode 6: 32	Mode 1: This mode cyclesthe following modesMode 2: 41.2Mode 3: 42Mode 4: 39.6Mode 5: 35.2Mode 6: 33.6	Similar(Note 1)
Maximumoutput current(mA+/-20%) at10KΩ	Mode 1: 9Mode 2: 9Mode 3: 8.6Mode 4: 9Mode 5: 9Mode 6: 9	Mode 1: This mode cyclesthe following modesMode 2: 12.9Mode 3: 12Mode 4: 8.5Mode 5: 12.1Mode 6: 12.4	Similar(Note 1)
Pulse period(mSec)	20~500	10~833	Similar(Note 1)
Frequency(Hz)	Mode 1: 5Mode 2: 20Mode 3: 50Mode 4: 50Mode 5: 10~50Mode 6: 2HZ (50Hz mixed with 2Hz)	Mode 1: This mode cyclesthe following modesMode 2: 69.4Mode 3: 13.0~52.1Mode 4: 1.2Mode 5: 96.2Mode 6: 96.2	Similar(Note 1)
MaximumPhasecharge(µC) at500Ω	Mode 1: 27.6Mode 2: 25.92Mode 3: 17.52Mode 4: 17.52Mode 5: 26.4Mode 6: 17.52	Mode 1: This mode cyclesthe following modesMode 2: 15.1Mode 3: 25.6Mode 4: 18.2Mode 5: 12.8Mode 6: 10.1	Similar(Note 1)
Maximumchargedensity(mA/cm²)) at 500Ω	Mode 1: 0.325(arm)/0.112(abs)Mode 2: 0.61(arm)/0.21(abs)Mode 3: 0.653(arm)/0.225(abs)Mode 4: 0.653(arm)/0.225(abs)Mode 5: 0.435~~0.984(arm)/0.15~~0.34(abs)Mode 6: 0.131(arm)/0.045(abs)	Mode 1:This mode cyclesthe following modesMode 2: 2.18Mode 3: 3.56Mode 4: 3.16Mode 5: 1.84Mode 6: 1.76	Similar(Note 1)
Maximumaverage powerdensity(mW/cm²)) at 500Ω	Mode 1: 14.94(arm)/5.15(abs)Mode 2: 26.33(arm)/9.08(abs)Mode 3: 19.07(arm)/6.57(abs)Mode 4: 19.07(arm)/6.57(abs)Mode 5: 19.15~~43.28(arm)/6.6~~14.92(abs)Mode 6: 3.81(arm)/1.31(abs)	Mode 1: This mode cyclesthe following modesMode 2: 1.14Mode 3: 0.64~2.56Mode 4: 0.03Mode 5: 1.13Mode 6: 0.85	Similar(Note 1)

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Table 2: Basic Unit Characteristics Comparison Table.

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Note 1:

As shown in the above comparison Table, the six modes of the subject device, have the technical characteristics (such as maximum output voltage, maximum output current, maximum current density, and maximum average power density) in similarity to the predicate device. Accordingly, we are substantially equivalent to the predicate device Electronic Pulse Stimulator (K153520).

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Design and Technology The basic design and technology of providing electrical stimulation is the same or similar. Performance and Specifications - The subject device has similar electrical stimulation and specifications to the predicate device.
Indications - The indications are same.

Review of Differences:

Pulse Width

The difference in pulse width between the subject device and the predicate device is having different sensation when delivered to human body.Different pulse width will lead to different output charge.The bigger pulse width has more energy than smaller pulse width. A large mount of charge will gives more obvious sensation to human body, but the charge is still within the required safety performance range according to the safety calculation. Therefore the difference does not raise different types of questions of safety and effectiveness as compared to the predicate devices.

Maximum Phase Charge

The reason that the subject device's phase charge is higher than the predicate is because the allowed voltage is higher than predicate device's at 500Ω. However, the subject device's phase charge is still in the safety range. In addition, the negative phase charge and the positive phase charge are always balanced out. Therefore, the difference does not raise different types of questions of safety and effectiveness as compared to the predicate devices.

Frequency range

Frequency for the subject device is 2~~50Hz and it falls into the subject device frequency of 1.2~~96.5Hz. So the difference doesn't raise different types of questions of safety and effectiveness.

As demonstrated, the differences between the subject and predicate devices do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, safety, and effectiveness as the predicate device.

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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1) Electrical safety

IEC60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.

Electromagnetic compatibility(EMC) 2)

IEC 60601-1-2:2014 Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests.

3) Basic Safety And Essential Performance

IEC 60601-1-11 Edition 2.0 2015-01 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment.

IEC 60601-2-10:2012 medical electrical equipment - part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators.

IEC 60601-1-6 Edition 3.1 2013 Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability.

4) Software Verification and Validating Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.

5) Biocompatibility testing

ISO 10993-1:2009 Biological evaluation of medical devices-Parts 1: Evaluation and testing.

ISO 10993-5:2009 Biological evaluation of medical devices-Parts 5: Tests for In Vitro cytotoxicity.

ISO 10993-10:2010 Biological evaluation of medical devices-Parts 10: Tests for irritation and skin sensitization.

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9. Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The proposed device is the same as the predicate device but the two devices are different. A series of safety and performance tests were conducted on the subject device:

Shelf Life

Biocompatibility

Software Validation

Electromagnetic compatibility and electrical safety

Function test (Including output waveforms, stimulation parameters and current distribution on the electrodes)

All the test results demonstrate Electrical Stimulator System meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices.

10. Clinical Tests Performed

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

11. Conclusion

The subject devices have all features of the predicate devices. The few differences do not affect the safety and effectiveness of the subject devices.

Thus, the subject devices are substantially equivalent to the predicate devices.

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).