Who is the manufacturer of Electrical Stimulator System?

Gymmax Technology Shenzen Co., Ltd. filed the 510(k) submission for Electrical Stimulator System (K192201).

What is the FDA product code for Electrical Stimulator System?

NUH. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Electrical Stimulator System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Electrical Stimulator System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Electrical Stimulator System

K192201 · Gymmax Technology Shenzen Co., Ltd. · NUH · Jun 12, 2020 · Neurology

Device Facts

Record ID	K192201
Device Name	Electrical Stimulator System
Applicant	Gymmax Technology Shenzen Co., Ltd.
Product Code	NUH · Neurology
Decision Date	Jun 12, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

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) 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 Story

Electrical Stimulator System delivers biphasic, symmetrical electrical pulses to user's body via electrode pads or garments. Device features multiple modes for TENS (pain relief) and PMS/EMS (muscle performance). User operates device via interface buttons (ON/OFF, intensity, mode selection). TENS mode blocks pain signals; PMS mode induces muscle contraction/relaxation to mimic exercise. Used in home healthcare environment. Benefits include temporary pain relief, improved muscle tone, and increased local blood circulation. Powered by rechargeable battery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), and performance testing (IEC 60601-2-10). Biocompatibility verified per ISO 10993-1, -5, and -10.

Technological Characteristics

Rechargeable battery-powered transcutaneous electrical nerve/muscle stimulator. Biphasic, symmetrical waveform. Pulse width 100-300µs; frequency 2-50Hz. Connectivity: wired electrodes/garments. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993. Software: Moderate level of concern.

Indications for Use

Indicated for temporary relief of pain associated with sore/aching muscles (shoulder, waist, back, arm, leg) due to exercise or daily activities; symptomatic relief/management of chronic, intractable pain; relief of arthritis-associated pain. Also indicated for healthy individuals to improve/facilitate muscle performance, tone, and firmness in arms, abdomen, legs, and buttocks, and to temporarily increase local blood circulation in healthy lower extremity muscles. Not for treatment of medical conditions or diseases.

Regulatory Classification

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.

Predicate Devices

Electronic Pulse Stimulator (K153520)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) 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. | 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 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 {4}------------------------------------------------ - 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 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 {5}------------------------------------------------ ### 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) 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. #### 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. {6}------------------------------------------------ # Table 1: Technological Characteristics | Elements of Comparison | Proposed Device | Predicate Device | Judgment | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Company Name | Gymmax Technology Shenzhen Co., Ltd. | JKH Health Co., Ltd | / | | Device Name | Electrical Stimulator System | Electronic Pulse Stimulator | / | | Classification Product Code | NUH | NUH | SE | | Subsequent Product Codes | NGX, NYN | NGX, NYN | SE | | Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | SE | | Classification Name | Transcutaneous electrical nerve stimulator for pain relief | Transcutaneous electrical nerve stimulator for pain relief | SE | | Class | 2 | 2 | SE | | Prescription or OTC | OTC | OTC | SE | | Functions and design | Electrical stimulation | Electrical stimulation | SE | | Power Source(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 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 2,3,4,5) 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. | 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 1 and 3) 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. | 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 IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | Conformance with IEC 60601-2-10:2012 medical electrical equipment - part 2-1 | SE | | Waveform | Biphasic, symmetrical | Biphasic, symmetrical | SE | | Pulse width | 300µs-100µs -300µs Image: Pulse width for proposed device | 100µs -100µs -100µs Image: Pulse width for predicate device | Similar (Note 1) | | Maximum output voltage (volts+/-20%) at 500Ω | Mode 1: 46 Mode 2: 43.2 Mode 3: 29.2 Mode 4: 29.2 Mode 5: 44 Mode 6: 29.2 | Mode 1: This mode cycles the following modes Mode 2: 39.2 Mode 3: 64 Mode 4: 56.8 Mode 5: 33.2 Mode 6: 31.6 | Similar (Note 1) | | Maximum output voltage (volts+/-20%) at 2KΩ | Mode 1: 75 Mode 2: 80 Mode 3: 64 Mode 4: 63 Mode 5: 82 Mode 6: 64 | Mode 1: This mode cycles the following modes Mode 2: 82.4 Mode 3: 84 Mode 4: 79.2 Mode 5: 70.4 Mode 6: 67.2 | Similar (Note 1) | | Maximum output voltage (volts+/-20%) at 10KΩ | Mode 1: 90 Mode 2: 90 Mode 3: 86 Mode 4: 90 Mode 5: 90 Mode 6: 90 | Mode 1: This mode cycles the following modes Mode 2: 129 Mode 3: 120 Mode 4: 84.8 Mode 5: 121 Mode 6: 124 | Similar (Note 1) | | Maximum output current (mA+/-20%) at 500Ω | Mode 1: 92 Mode 2: 86.4 Mode 3: 58.4 Mode 4: 58.4 Mode 5: 88 Mode 6: 58.4 | Mode 1: This mode cycles the following modes Mode 2: 78.4 Mode 3: 128 Mode 4: 113.6 Mode 5: 64.4 Mode 6: 63.2 | Similar (Note 1) | | Maximum output current (mA+/-20%) at 2KΩ | Mode 1: 37.5 Mode 2: 40 Mode 3: 64 Mode 4: 31.5 Mode 5: 41 Mode 6: 32 | Mode 1: This mode cycles the following modes Mode 2: 41.2 Mode 3: 42 Mode 4: 39.6 Mode 5: 35.2 Mode 6: 33.6 | Similar (Note 1) | | Maximum output current (mA+/-20%) at 10KΩ | Mode 1: 9 Mode 2: 9 Mode 3: 8.6 Mode 4: 9 Mode 5: 9 Mode 6: 9 | Mode 1: This mode cycles the following modes Mode 2: 12.9 Mode 3: 12 Mode 4: 8.5 Mode 5: 12.1 Mode 6: 12.4 | Similar (Note 1) | | Pulse period (mSec) | 20~500 | 10~833 | Similar (Note 1) | | Frequency(Hz) | Mode 1: 5 Mode 2: 20 Mode 3: 50 Mode 4: 50 Mode 5: 10~50 Mode 6: 2HZ (50Hz mixed with 2Hz) | Mode 1: This mode cycles the following modes Mode 2: 69.4 Mode 3: 13.0~52.1 Mode 4: 1.2 Mode 5: 96.2 Mode 6: 96.2 | Similar (Note 1) | | Maximum Phase charge(µC) at 500Ω | Mode 1: 27.6 Mode 2: 25.92 Mode 3: 17.52 Mode 4: 17.52 Mode 5: 26.4 Mode 6: 17.52 | Mode 1: This mode cycles the following modes Mode 2: 15.1 Mode 3: 25.6 Mode 4: 18.2 Mode 5: 12.8 Mode 6: 10.1 | Similar (Note 1) | | Maximum charge density(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 cycles the following modes Mode 2: 2.18 Mode 3: 3.56 Mode 4: 3.16 Mode 5: 1.84 Mode 6: 1.76 | Similar (Note 1) | | Maximum average power density(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 cycles the following modes Mode 2: 1.14 Mode 3: 0.64~2.56 Mode 4: 0.03 Mode 5: 1.13 Mode 6: 0.85 | Similar (Note 1) | {7}------------------------------------------------ {8}------------------------------------------------ # Table 2: Basic Unit Characteristics Comparison Table. {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ ### 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). {12}------------------------------------------------ - 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: {13}------------------------------------------------ ### 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. {14}------------------------------------------------ #### 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.

Electrical Stimulator System

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Electrical Stimulator System

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Indications for Use

Device Story

Clinical Evidence

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Indications for Use

Regulatory Classification

Identification

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