(136 days)
No
The summary describes a TENS device with pre-set programs and adjustable intensity, controlled via an app or remote. There is no mention of AI or ML in the device description, intended use, or performance studies. The software is described as "Moderate" level of concern and follows IEC 62304, which is standard for medical device software and doesn't inherently imply AI/ML.
Yes
The device is described as a "Wireless Pain Relieve Device" that uses Transcutaneous Electrical Nerve Stimulation (TENS) for "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." This falls under the definition of a therapeutic device as it is intended to treat or relieve a medical condition (pain).
No
The device description states that TENS does not cure any physiological problem; it only helps control the pain, which aligns with therapeutic use rather than diagnostic. The intended use also focuses on pain relief.
No
The device description explicitly states it includes hardware components (TENS mode, self-adhesive electrodes) and mentions hardware-related performance testing (Electrical safety and electromagnetic compatibility, Output waveform Testing). While it is controlled by software (APP), it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief and management of pain through electrical stimulation (TENS). This is a therapeutic application, not a diagnostic one.
- Device Description: The device description clearly states it uses TENS to modify pain perception by sending electrical impulses through the skin to nerves. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis or monitoring of a disease or condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Product codes
NYN, NUH
Device Description
LT5011C is designed to be used at home, by adults of all genders.
The Wireless Pain Relieve Device includes TENS mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain.
TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves.
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 23 pre-set TENS programs. In each program, the intensity can be adjusted.
The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) or remote control. The communication is done via Bluetooth Low Energy. The APP operates on iOS or Android platforms (iOS 8.0 or greater, Android 5.0 or greater).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, upper extremities (arm) and lower extremities (leg)
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home, by adults of all genders.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data are provided in support of the substantial equivalence determination:
7.1 Biocompatibility testing
Compared with unmodified device, the material of electrodes for the new product LT5011C is the same material of predicate device (K173462) that got the 510(k) clearance on 2017. The material of enclosure is ABS, and it is the same as the material of predicate device (K173462) that got the 510(k) clearance on 2017. These materials have the same product process and injection process.
7.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LT5011C. The system complies with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
For FCC part 15 RADIO FREQUENCY DEVICES, Subpart C—Intentional Radiators.
7.3 Software Verification and Validation 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. IEC 62304 was followed.
7.4 Output waveform Testing
For each program, oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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June 22, 2018
Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan R.A. Specialist No. 3 Building Xiliba imang Xusheng Industrial Estate Nansha Shenzhen, China 518108
Re: K180331
Trade/Device Name: Wireless Pain Relieve Device, Model LT5011C Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NYN, NUH Dated: May 15, 2018 Received: May 21, 2018
Dear Siping Yuan:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela D. Scott -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180331
Device Name Wireless Pain Relieve Device Model: LT5011C
Indications for Use (Describe)
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 201.5 Labeling) | Over-The-Counter Use (21 CFR 201.5 Labeling) |
|---|---|
| --------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------- |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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005_510 (k) Summary Version: 1.1
510(k) SUMMARY
as required by section 21 CFR 807.92
Wireless Pain Relieve Device
| Date of Submission: | 02/01/2018 |
|---|---|
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd |
| Address: | No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan, Shenzhen, CHINA 518108 |
| E-mail: | ra@dundex.com |
| Tel: | +86(755) 27652471 |
| FAX: | +86(755) 27652674 |
| Contact: | Siping Yuan |
4
005 510 (k) Summary Version: 1.1
TECHNOLOGY CO., LTD.
| 1. Proposed Device:
| |
| ------------------------- | -- |
|---|
Device Name: Wireless Pain Relieve Device
Model: LT5011C
| Device classification Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
|---|---|
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Medical Specialty: | Neurology |
| Review Panel: | Neurology |
| Regulation Number: | 882.5890 |
| Product Code: | NUH |
| Device Class: | II |
| Device classification Name: | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relief |
| Regulation Medical Specialty: | Neurology |
| Review Panel: | Neurology |
| Regulation Number: | 882.5890 |
| Product Code: | NYN |
| Device Class: | II |
2. Predicate Device:
| Legally Marketed Device: | Wireless Pain Relieve Device LT5018C |
|---|---|
| 510(k) Number: | K173462 |
| Manufacturer: | Shenzhen Dondixin Technology Co., Ltd |
3. Description of Proposed Device:
LT5011C is designed to be used at home, by adults of all genders.
Explanation of how the device functions:
The Wireless Pain Relieve Device includes TENS mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain.
Scientific concepts that from the basis for the device:
TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves.
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 23 pre-set TENS programs. In each program, the intensity can be adjusted.
5
Image /page/5/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is composed of the company name in a bold, sans-serif font, with the letters 'X' stylized in orange. To the right of the English name, the company name is also written in Chinese characters.
The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) or remote control. The communication is done via Bluetooth Low Energy. The APP operates on iOS or Android platforms (iOS 8.0 or greater, Android 5.0 or greater).
4. Description of All Device Modification(s)
Compared with the existing device (LT5018C), the following main parts of Wireless Pain Reliever LT5018C have changed:
-
- Change the dimensional specification and change the hardware based on the new dimension of enclosure. But the fundamental scientific technology does not change.
-
- Remove the EMS program and indications for use of EMS mode.
-
- Remove the neck program and indications for use of neck pain.
- Split the cycle program of unmodified device into four programs for users to choose their 4) comfortable programs and add custom program for users to choose their comfortable programs.
Based on the 21CFR820.30 requirement, this is belong to design change and shall have been evaluated according to the standard IEC60601-2-10, and IEC 60601-1-2. We have conducted these standard test and the results is Passed.
5. Proposed Device Intended for Use Statement:
Device Name: Wireless Pain Relieve Device, Model: LT5011C
Indications for Use:
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
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Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold letters, with the "X" in "DIXIN" being yellow. Below "DONGDIXIN" is the text "TECHNOLOGY CO., LTD." in smaller letters, also in blue. To the right of the English text is the company name in Chinese.
6. Technological Characteristics and Substantial Equivalence
Both the IT5011C and Predicate Device utilize the application of electrodes placed on the skin for pain control. The impulses are generated by the device and delivered through electrodes on the skin in direct proximity to the (painful) muscles to be stimulated. Basic technological characteristics, new device vs. Predicate device
| New device | Predicate device | S.E. Discussion | ||
|---|---|---|---|---|
| 1 | 510K# | To be assigned | K173462 | N/A |
| 2 | Device Name and | |||
| Model | Wireless Pain Relieve device | |||
| Mode: LT5011C | Wireless Pain Relieve device | |||
| Mode: LT5018C | N/A | |||
| 3 | Manufacturer | Shenzhen Dongdixin Technology Co., Ltd | Shenzhen Dongdixin Technology Co., Ltd | Same |
| 4 | Intended for use | TENS: The device is designed to be used for | ||
| temporary relief of pain associated with | ||||
| sore and aching muscles in the shoulder, | ||||
| waist, back , upper extremities (arm) and | ||||
| lower extremities (leg) due to strain from | ||||
| exercise or normal household work | ||||
| activities. And to be used for the | ||||
| symptomatic relief and management of | ||||
| chronic, intractable pain and relief of pain | ||||
| associated with arthritis. | TENS: The device is designed to be used | |||
| for temporary relief of pain associated | ||||
| with sore and aching muscles in the | ||||
| shoulder, waist, back, neck, upper | ||||
| extremities (arm) and lower extremities | ||||
| (leg) due to strain from exercise or normal | ||||
| household work activities. And to be used | ||||
| for the symptomatic relief and | ||||
| management of chronic, intractable pain | ||||
| and relief of pain associated with arthritis. | ||||
| EMS: The device is designed to be used | ||||
| for stimulate healthy muscles in order to | ||||
| improve and facilitate muscle | ||||
| performance. | Similar, the intended use of | |||
| LT5011C is fallen within the | ||||
| intended use of predicate | ||||
| device. | ||||
| 5 | Power Source | DC 3.7V Li-ion Battery(main device) | ||
| DC 3.0V, 2 x AAA Batteries (Remote control) | DC 3.7V Li-ion Battery(main device) | |||
| DC 3.0V, 2 x AAA Batteries (Remote | ||||
| control) | Same | |||
| -Method of | ||||
| current isolation | N/A | N/A | Same | |
| - Patient Leakage | ||||
| Current (μΑ) | Same | |||
| -Normal condition | 0uA | 0uA | ||
| -Single fault | ||||
| condition | 2.0uA | 2.0uA | ||
| 6 | Average DC current through electrodes when device is on but no pulses are being applied (µA) | 0 | 0 | Same |
| 7 | Number of Output Modes | 1 (TENS) | 2 (TENS/EMS(including MASSAGE)) | Different, LT5011C only has TENS mode and LT5011C remove indications for use of EMS mode accordingly. |
| 8 | Number of Output Channels | |||
| Synchronous or Alternating? | Alternating | N/A | Different, LT5011C has two channels and have been evaluated and passed the test according to the requirement of IEC60601-2-10. | |
| Method of Channel Isolation | By Electrical Circuit and Software | N/A | Different, LT5011C has two channels and have been evaluated and passed the test according to the requirement of IEC60601-1. | |
| 9 | Regulated Current or Regulated Voltage? | Current control | Current control | Same |
| 10 | Software/Firmware/Micro processor Control? | Yes | Yes | Same |
| 11 | Automatic Overload Trip | Yes | Yes | Same |
| 12 | Automatic No Load contact Trip | Yes | Yes | Same |
| 13 | Automatic Shut off | Yes | Yes | Same |
| 14 | User Override Control? | Yes | ||
| Power on/off button on the device | ||||
| Power on/off on the remote control | ||||
| Power on/off in the APP software | Yes | |||
| Power on/off button on the device | ||||
| Power on/off on the remote control | ||||
| Power on/off in the APP software | Same | |||
| 15 | Indicator Display: | |||
| On/Off Status? | Yes | Yes | Same | |
| Low Battery? | Yes | Yes | Same | |
| Voltage/ Current | ||||
| Level? | Yes | Yes | Same | |
| 16 | Timer Range (minutes) | 5-90 minutes | 30 minutes | Different, new device have been |
| evaluated and passed the test | ||||
| according to the requirement of | ||||
| IEC60601-2-10. | ||||
| User can set the treatment time | ||||
| according their needs. | ||||
| 17 | Weight (grams.) | 33grams (Main device) | ||
| 55 grams (Remote control) | 36grams (Main device) | |||
| 65 grams (Remote control) | Different, the new device have | |||
| been evaluated and passed the | ||||
| testing according to the | ||||
| requirement of IEC60601-1. | ||||
| 18 | Dimensions (cm.) H*W * | |||
| L | 80.5(L)x45(W)x13.5(H)mm (Main device) | |||
| 127(L)x48.7(W)x24.2(H)mm (Remote control) | 360(L)x59(W)x11.5(H)mm (Main device) | |||
| 115(L)x53(W)x25(H)mm (Remote control) | ||||
| 19 | Housing Materials & | |||
| Construction | ABS | ABS | Same | |
| 20 | Compliance with 21 CFR | |||
| 898 | Yes | Yes | Same | |
| 21 | Compliance with | |||
| Voluntary Standards? | IEC 60601-1, | |||
| IEC 60601-1-2, | ||||
| IEC 60601-2-10, | ||||
| IEC 60601-1-11 | ||||
| ISO10993-5/10 | IEC 60601-1, | |||
| IEC 60601-1-2, | ||||
| IEC 60601-2-10, | ||||
| IEC 60601-1-11 | ||||
| ISO10993-5/10 | Same | |||
| New device | Predicate device | S.E. Discussion | ||
| 1 | 510K# | To be assigned | K173462 | N/A |
| 2 | Device Name or | |||
| Program Name | Wireless Pain Relief Device | |||
| Mode:LT5011C | Wireless Pain Relief Device | |||
| Mode:LT5018C | N/A | |||
| 3 | Manufacturer | Shenzhen Dongdixin Technology Co., Ltd | Shenzhen Dongdixin Technology Co., Ltd | Same |
| 4 | Waveform | Biphasic | Biphasic | Same |
| 5 | Shape | Rectangular | Rectangular | Same |
| 6 | Max Output Voltage (V) ±20% | |||
| 7 | 500Ω | 30.5 | 31 | Similar, the new device have |
| been evaluated and passed | ||||
| the test according to the | ||||
| requirement of IEC60601-2-10 | ||||
| 8 | 2kΩ | 65 | 66 | |
| 9 | 10kΩ | 65 | 66 | |
| 10 | Pulse Duration | |||
| (µsec) | 100~200us | 150~250us | ||
| 11 | Frequency (Hz) | 2~100Hz | 2~100Hz | Same |
| 12 | Maximum Phase | |||
| Charge (uC) 500Ω | 24 | 31 | Similar, the new device have | |
| been evaluated and passed | ||||
| the test according to the | ||||
| requirement of | ||||
| IEC60601-2-10. | ||||
| 13 | Maximum Current | |||
| Density 500Ω | 0.295mA/cm² | 0.48mA/cm² | ||
| 14 | Maximum Average | |||
| Current (average | ||||
| absolute value), | ||||
| mA, 500Ω | 1.2 | 1.2 | ||
| 15 | Maximum Average | |||
| Power Density, | ||||
| (mW/cm²).500Ω | 1.74 | 2.88 |
Table 1: Substantial Equivalence Comparison Table
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Image /page/7/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The text "TECHNOLOGY CO., LTD." is in a smaller font size than the company name. There are also three Chinese characters to the right of the company name.
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Image /page/8/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The text "DONGDIXIN" is in large, bold, blue letters, with a yellow "X" in the middle. Below the company name is the text "TECHNOLOGY CO., LTD." in smaller, blue letters. To the right of the company name are three Chinese characters in blue.
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Image /page/9/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo features the company name in a bold, sans-serif font, with the "X" in "DIXIN" stylized in orange. To the right of the English name is the company name in Chinese characters.
Table 2: Output Specification TENS mode
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Image /page/10/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is composed of the company name in a bold, sans-serif font, with the "X" in "DIXIN" stylized in orange. To the right of the English name is the company name in Chinese characters. The overall design is clean and modern.
Discussion:
The number of output modes, number of output channels, timer range, weight and dimension of the new device are different from the predicate devices, but the new devices are evaluated and passed the testing according to IEC60601-1 and IEC60601-2-10, this difference does not pose any new questions of safety.
The Max Output Voltage/Current, Pulse Duration, Maximum Phase Charge, Maximum Current Density and Maximum Average Power Density are similar with the predicate devices, but the new devices are evaluated and passed the testing according to IEC60601-2-10, this difference doesn't pose any new questions of safety and effectiveness.
7. Performance Data:
The following performance data are provided in support of the substantial equivalence determination:
7.1 Biocompatibility testing
Compared with unmodified device, the material of electrodes for the new product LT5011C is the same material of predicate device (K173462) that got the 510(k) clearance on 2017. The material of enclosure is ABS, and it is the same as the material of predicate device (K173462) that got the 510(k) clearance on 2017. These materials have the same product process and injection process.
7.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LT5011C. The system complies with the IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
For FCC part 15 RADIO FREQUENCY DEVICES, Subpart C—Intentional Radiators.
7.3 Software Verification and Validation 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. IEC 62304 was followed.
7.4 Output waveform Testing
For each program, oscilloscope tracing diagrams describing the electrical output waveform was provided to verify the output specifications of the device according to IEC 60601-2-10.
8. Conclusions
The LT5011C has the similar intended use and technological characteristics as the predicate device Wireless Pain Relieve Device LT5018C. Moreover, bench testing and safety report supplied in this submission demonstrates that the difference in the submitted models could
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005_510 (k) Summary Version: 1.1
maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, LT5011C is substantially equivalent to the predicate device.