(304 days)
None
No
The document describes a standard electrical stimulator with multiple modes and intensity controls. There is no mention of AI, ML, or any adaptive or learning capabilities. The performance studies focus on electrical safety, EMC, and functional testing against pre-defined criteria, not on algorithmic performance or training/test data.
Yes.
The device's intended use includes "temporary relief of pain associated with sore and aching muscles" and "symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis," which are therapeutic applications.
No
The device is described as an Electrical Stimulator System used for temporary pain relief and muscle stimulation, not for diagnosing conditions.
No
The device description explicitly details hardware components such as an ON/OFF button, intensity buttons, mode selection button, and the device itself which attaches to electrodes. It also lists accessories like electrode pads, garments, and a USB cable. This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an electrical stimulator that delivers electrical pulses to the user's body through electrodes. It is used for pain relief (TENS) and muscle stimulation (PMS).
- Intended Use: The intended uses described are related to pain management and muscle performance, not the analysis of biological specimens.
The device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
NUH, NGX, NYN
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, arm, leg, abdomen, buttocks, lower extremities, neck, foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
- 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): 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.
- 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.
- 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.
- 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.
Non-clinical tests performed:
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.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
None
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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) |
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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) | 20500 | 10833 | Similar
(Note 1) |
| Frequency(Hz) | Mode 1: 5
Mode 2: 20
Mode 3: 50
Mode 4: 50
Mode 5: 105052.1
Mode 6: 2HZ (50Hz mixed with 2Hz) | Mode 1: This mode cycles
the following modes
Mode 2: 69.4
Mode 3: 13.0
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: 0.4350.984(arm)/0.34(abs)
0.15
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: 19.1543.28(arm)/14.92(abs)
6.6
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) |
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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 250Hz and it falls into the subject device frequency of 1.296.5Hz. 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.