(30 days)
No
The summary describes a standard TENS/EMS device controlled by an app, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes.
The device is intended for the temporary relief and management of pain and to improve and facilitate muscle performance, which are therapeutic purposes.
No
The device is described as providing temporary pain relief and muscle stimulation, not for identifying or diagnosing a medical condition.
No
The device description explicitly states it includes "The Wireless Pain Relieve Device" which has TENS and EMS modes and is controlled by an app and remote control, communicating via Bluetooth. This indicates the presence of hardware components (the device itself, remote control, and Bluetooth module) beyond just the software application. The performance studies also include electrical safety and EMC testing, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for pain relief and muscle stimulation, which are therapeutic applications. IVDs are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details electrical stimulation for therapeutic purposes (TENS and EMS). It does not mention analyzing biological samples.
- Anatomical Site: The device is applied to external anatomical sites (shoulder, waist, back, neck, extremities). IVDs typically interact with internal biological samples.
- Performance Studies: The performance studies focus on electrical safety, biocompatibility, and software validation, which are relevant for therapeutic devices, not IVDs.
The device is clearly described as a therapeutic device utilizing electrical stimulation for pain management and muscle performance.
N/A
Intended Use / Indications 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, 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.
Product codes
NUH, NGX, NYN
Device Description
LT5018C is designed to be used at home, by adults of all genders. The Wireless Pain Relieve Device includes TENS, EMS (including MASSAGE Program) mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively.
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. EMS is a product derived from the square waveform (ladder-shaped), through the square wave pattern it is able to work directly on muscle motor neurons, contraction helps to condition the muscle in order to facilitate performance.
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 6 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
For Electrical Muscle Stimulation (EMS), the electrodes are placed near the muscle to be stimulated. The user can choose 5 pre-set EMS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
There have 3 massage programs, and the massage stimulation program is a stimulation program that is used with the EMS mode of stimulation to facilitate recovery from muscle fatigue and to help recover muscle strength after training sessions and competitions.
The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) and remote control. The communication is done via Bluetooth Low Energy. The APP operates on IOS and 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, neck, upper extremities (arm), lower extremities (leg).
Indicated Patient Age Range
Adults.
Intended User / Care Setting
Used at home, by adults.
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 Testing: The Electrical safety and EMC testing were conducted on the LT5018C. 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.
Software Verification and Validation: 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.
Key Results: The bench testing and safety report demonstrate that the differences in the submitted models maintain the same safety and effectiveness as the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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December 8, 2017
Shenzhen Dongdixin Technology Co.,Ltd. Siping Yuan R.A. Specialist No. 3 Building Xilibaimang Xusheng Industrial Estate, Nanshan Shenzhen, Guangdong 51808 China
Re: K173462
Trade/Device Name: Wireless Pain Relieve Device, Model LT5018C 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: October 31, 2017 Received: November 8, 2017
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
1
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); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Vivek J. Pinto -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
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Indications for Use
510(k) Number (if known) K173462
Device Name Wireless Pain Relieve Device Model: LT5018C
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | Residential Use (Part 21 CFR 601 Subpart E) Over-The-Counter Use (21 CFR 601 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------ |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and yellow. The text "DONGDIXIN TECHNOLOGY CO., LTD." is written in a sans-serif font. There are also three Chinese characters to the right of the English text.
001_510 (k) Summary Version: 1.0
510(k) SUMMARY
as required by section 21 CFR 807.92
Wireless Pain Relieve Device
| Date of Submission: | 10/31/2017 |
|---|---|
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd |
| Address: | No. 3 Building, Xilibaimang Xusheng Industrial |
| Estate Nanshan, Shenzhen, CHINA 518108 | |
| E-mail: | yuansp@dundex.com |
| Tel: | +86(755) 27652471 |
| FAX: | +86(755) 27652674 |
| Contact: | Siping Yuan |
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DONGDIXIN翡
001 510 (k) Summary ı: 1.0
| | TECHNOLOGY CO., LTD.
厅灾 | Version: | | |
|----|-------------------------------------------|-------------------------------------------------------------|--|--|
| 1. | Proposed Device: | | | |
| | Device Name: Wireless Pain Relieve Device | | | |
| | Model: LT5018C | | | |
| | 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: | ll | | |
| | Device classification Name: | Stimulator, Muscle, Powered, For Muscle Conditioning | | |
| | Regulation Description: | Powered muscle stimulator. | | |
| | Regulation Medical Specialty: | Physical Medicine | | |
| | Review Panel: | Physical Medicine | | |
| | Regulation Number: | 890.5850 | | |
| | Product Code: | NGX | | |
| | Device Class: | = | | |
| | 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: | = | | |
| 2. | Predicate Device: | | | |
| | | Lorally Markatad Davira. Smart Dain Rollovar IT501Q | | |
Legally Marketed Device: Smart Pain Reliever LT5019 510(k) Number: K162479 Manufacturer: Shenzhen Dondixin Technology Co., Ltd.
Description of Proposed Device: 3.
LT5018C 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, EMS (including MASSAGE Program) mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this
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Image /page/5/Picture/1 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue and orange, with the company name in large letters. Below the company name is the phrase "TECHNOLOGY CO., LTD." in smaller letters. There is also some text in another language to the right of the company name, and the phrase "causes the muscle to exercise passively." is at the bottom.
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. EMS is a product derived from the square waveform (ladder-shaped), through the square wave pattern it is able to work directly on muscle motor neurons, contraction helps to condition the muscle in order to facilitate performance.
For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 6 pre-set TENS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
For Electrical Muscle Stimulation (EMS), the electrodes are placed near the muscle to be stimulated. The user can choose 5 pre-set EMS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
There have 3 massage programs, and the massage stimulation program is a stimulation program that is used with the EMS mode of stimulation to facilitate recovery from muscle fatigue and to help recover muscle strength after training sessions and competitions.
The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) and remote control. The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).
Description of All Device Modification(s) 4.
Compared with the existing device (LT5019), the following main parts of Wireless Pain Reliever LT5018C have changed:
-
- Added the remote control to control the operation of device.
-
- Change the dimensional specification.
-
- Change the hardware based on the new dimensional of enclosure. But the fundamental scientific technology is not change.
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. Meanwhile, for add the remote control; we added the wireless coexistence test and the results display the remote control also safely and effectively.
5. Proposed Device Intended for Use Statement:
Device Name: Wireless Pain Relieve Device, Model: LT5018C
Indications for Use:
- � TENS: The device is designed to be used for temporary relief of pain associated with
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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.
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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 "DONGDIXIN" is in large, bold, blue letters, with a yellow design element in the middle. Below that, the text "TECHNOLOGY CO., LTD." is in smaller, blue letters.
6. Technological Characteristics and Substantial Equivalence
Both the LT5018C and Predicate Device the application of electrical current through electrodes placed on the skin for pain control, or electrical muscle stimulation (EMS) the elicitation of muscle contraction using electric 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 | K162479 | N/A |
| 2 | Device Name and | |||
| Model | Wireless Pain Relieve device | |||
| Mode: LT5018C | Smart Pain Reliever | |||
| Mode: LT5019 | 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, 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. | 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. | Same | |||
| 5 | Power Source | 3.7V battery supply | 3.7V battery supply | Same |
| -Method | ||||
| of | ||||
| current isolation | Line N/A | N/A | Same | |
| - Patient Leakage | ||||
| Current (μΑ) | ||||
| -Normal condition | 0uA | 0uA | Same | |
| -Single fault | ||||
| condition | 2.0uA | 2.0uA | ||
| 6 | DC current | |||
| Average | ||||
| electrodes | ||||
| through | ||||
| when device is on but | ||||
| no pulses are being | ||||
| applied (μΑ) | 0 | 0 | Same | |
| 7 | Number of Output | |||
| Modes | 2 (TENS/EMS(including MASSAGE)) | 2 (TENS/EMS(including MASSAGE)) | Same | |
| 8 | Number of Output Channels | |||
| Synchronous or | ||||
| Alternating? | N/A | N/A | Same | |
| Method of Channel | ||||
| Isolation | N/A | N/A | Same | |
| ਰੇ | Regulated Current or | |||
| Regulated Voltage? | Current control | Current control | Same | |
| 10 | Software/Firmware/Mi | |||
| cro 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, and | ||||
| Power on/off in the APP software | Similar, the new device added | |||
| the remote control, doesn't | ||||
| affect the safety and | ||||
| effectiveness. | ||||
| 15 | Indicator Display: | |||
| On/Off Status? | Yes | Yes | Same | |
| Low Battery? | Yes | Yes | Same | |
| Voltage/ Current | Yes | Yes | Same |
Table 1: Substantial Equivalence Comparison Table
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| Level? | ||
|---|---|---|
| -------- | -- | -- |
Table 2: Output Specification TENS mode
| New device | Predicate device | S.E. Discussion | |||
|---|---|---|---|---|---|
| 1 | 510K# | To be assigned | K162479 | N/A | |
| 2 | Device Name or | ||||
| Program Name | Wireless Pain Relief Device | ||||
| Mode:LT5018C | Smart Pain Reliever | ||||
| Mode: LT5019 | 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 | 31 | 31.2 | Similar, the new device have | |
| 8 | 2kΩ | 66 | 69.6 | been evaluated and passed the | |
| 9 | 10kΩ | 66 | 69.6 | test according to the | |
| requirement of IEC60601-2-10 | |||||
| 10 | Pulse Duration | ||||
| (µsec) | 150~250us | 150~250us | Same | ||
| 11 | Frequency (Hz) | 2~100Hz | 2~100Hz | Same | |
| 12 | Maximum Phase | ||||
| Charge (uC) 500Ω | 31 | 30 | Similar, the new device have | ||
| been evaluated and passed | |||||
| 13 | Maximum Current | ||||
| Density 500Ω | 0.48mA/cm² | 0.32mA/cm² | the test according to the | ||
| requirement of | |||||
| IEC60601-2-10. | |||||
| 14 | Maximum Average | ||||
| Current (average | |||||
| absolute value), | |||||
| mA, 500Ω | 1.2 | 1.2 | The maximum average power | ||
| density of new device is far | |||||
| lower than 250mW/cm2 as | |||||
| required by the FDA guidance | |||||
| for Powered Muscle | |||||
| Stimulator. The safety and | |||||
| effectiveness of the device is | |||||
| not affected. | |||||
| 15 | Maximum Average | ||||
| Power Density, | |||||
| (mW/cm²),500Ω | 2.88 | 1.9 |
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Table 3: Output Specification EMS mode
| New device | Predicate device | S.E. Discussion | |||
|---|---|---|---|---|---|
| 1 | 510K# | To be assigned | K162479 | N/A | |
| 2 | Device Name or | ||||
| Program Name | Wireless Pain Relief Device | ||||
| Mode:LT5018C | Smart Pain Reliever | ||||
| Mode: LT5019 | 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 | 31 | 31.2 | Similar, the new device have | |
| been evaluated and passed the | |||||
| test according to the | |||||
| requirement of IEC60601-2-10 | |||||
| 8 | 2kΩ | 66 | 69.6 | Same | |
| 9 | 10kΩ | 66 | 69.6 | Similar, the new device have | |
| been evaluated and passed the | |||||
| test according to the | |||||
| requirement of IEC60601-2-10 | |||||
| 10 | Pulse Duration (usec) | 200~370us | 200~370us | Same | |
| 11 | Frequency (Hz) | 3-55 Hz | 3~75Hz | Similar, the new device have | |
| been evaluated and passed the | |||||
| test according to the | |||||
| requirement of IEC60601-2-10 | |||||
| 12 | Maximum Phase | ||||
| Charge (uC) 500Ω | 44.4 | 24 | Similar, the new device have | ||
| been evaluated and passed the | |||||
| test according to the | |||||
| requirement of IEC60601-2-10 | |||||
| 13 | Maximum Current | ||||
| Density 500Ω | 0.484mA/cm2 | 0.248mA/cm2 | Similar, the new device have | ||
| been evaluated and passed the | |||||
| test according to the | |||||
| requirement of IEC60601-2-10. | |||||
| 14 | Maximum Average | ||||
| Current (average | |||||
| absolute value), mA, | |||||
| 500Ω | 1.22 | 0.72 | The maximum average power | ||
| density of new device is far | |||||
| lower than 250mW/cm2 as | |||||
| required by the FDA guidance | |||||
| for Powered Muscle | |||||
| Stimulator. The safety and | |||||
| effectiveness of the device is | |||||
| not affected. | |||||
| 15 | Maximum Average | ||||
| Power Density, | |||||
| (mW/cm²),500Ω | 2.93 | 1.2 | |||
| New device | Predicate device | S.E. Discussion | |||
| 1 | 510K# | To be assigned | K162479 | N/A | |
| 2 | Device | ||||
| Name | |||||
| or | Wireless Pain Relief Device | Smart Pain Reliever | N/A | ||
| Program Name | Mode:LT5018C | Mode: LT5019 | |||
| 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% | Similar, the new device have | |||
| 7 | 500Ω | 31 | 31.2 | been evaluated and passed the | |
| 8 | 2kΩ | 66 | 69.6 | test according to the | |
| 9 | 10kΩ | 66 | 69.6 | requirement of IEC60601-2-10 | |
| 10 | Pulse Duration (usec) | 50-250us | 250us | Similar, the new device have | |
| 11 | Frequency (Hz) | 2~90Hz | 10~80Hz | been evaluated and passed the | |
| test according to the | |||||
| requirement of IEC60601-2-10 | |||||
| 12 | Maximum Phase | 31 | 30 | Similar, the new device have | |
| Charge (uC) 500Ω | been evaluated and passed the | ||||
| 13 | Maximum | ||||
| Current | 0.51mA/cm2 | 0.32mA/cm2 | test according to the | ||
| Density 500Ω | requirement of IEC60601-2-10. | ||||
| 14 | Maximum | ||||
| Average | 3.2 | 1.9 | The maximum average power | ||
| Power | |||||
| Density, | density of new device is far | ||||
| (mW/cm²),500Ω | lower than 250mW/cm2 as | ||||
| required by the FDA guidance | |||||
| for Powered Muscle | |||||
| Stimulator. The safety and | |||||
| effectiveness of the device is | |||||
| not affected. |
11
Table 4: Output Specification MASSAGE program
12
TECHNOLOGY CO., LTD.
Discussion
The 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 Different does not pose any new questions of safety and effectiveness. The Housing Material, Max Output Voltage/Current, Maximum Phase Charge, Maximum Current Density and Maximum Average Current/Power Density are similar with the predicate devices, but the new devices are evaluated and passed the testing according to IEC60601-2-10 and compliance with the guidance Document for Powered Muscle Stimulator, 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 LT5018C is the same material of electrodes (K162479) that got the 510(k) clearance on 2017. The material of enclosure is ABS, and it is the same as the material of enclosure (K130802) that got the 510(k) clearance on 2013. 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 LT5018C. 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.
8. Conclusions
The LT5018C has the same intended use and technological characteristics as the predicate device Smart Pain Reliever LT5019. Moreover, bench testing and safety report supplied in this submission demonstrates that the difference in the submitted models could 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, LT5018C is substantially equivalent to the predicate device.