(155 days)
Not Found
No
The summary describes a standard TENS/EMS device controlled by a mobile app via Bluetooth. There is no mention of AI, ML, or any features that would suggest adaptive learning, predictive capabilities, or complex data analysis beyond basic device control and program selection. The performance studies focus on safety, electrical parameters, software validation, and usability, not on the performance of an AI/ML algorithm.
Yes
The device is described with an "Intended Use" to provide temporary relief of pain and to stimulate muscles, and states it is a "Smart Pain Reliever," which are common functions of therapeutic devices.
No
The device is designed for therapeutic purposes (pain relief, muscle stimulation) rather than for diagnosing any medical condition.
No
The device description explicitly states "The Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table)." and the performance studies include "Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2, and IEC 62133." and "Bench testing was performed to characterize the waveform and stimulus parameters, and performance testing proved the ability of the device to deliver a stimulus that meets design specifications." These indicate the presence of hardware components (the Smart Pain Reliever device itself) that deliver the electrical stimulation, which is controlled by the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for pain relief and muscle stimulation. These are therapeutic applications, not diagnostic ones.
- Device Description: The description details the function of TENS and EMS, which are methods of applying electrical stimulation to the body for therapeutic purposes. It does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a hallmark of IVD devices.
- Lack of IVD-related terms: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on electrical safety, biocompatibility, software validation, and usability – all relevant to a therapeutic electrical stimulation device, but not to an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such function.
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
LT5019 is designed to be used at home, by adults of all genders.
The Smart Pain Reliever includes TENS, EMS (including MASSAGE Program). 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 11 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 8 pre-set EMS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
The Smart Pain Reliever device only have one massage program, and this 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 Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table). 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) and lower extremities (leg)
Indicated Patient Age Range
adults
Intended User / Care Setting
at home
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:
6.1 Biocompatibility testing
The biocompatibility evaluation for the LT5019 was conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process". As dictated by the application and duration of contact with the intact skin, the shell and electrode of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
6.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the LT5019. The system complies with the IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC, and IEC 62133 for battery safety.
6.3 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.
6.4 Usability Testing
Usability testing according to IEC 62366, Applying Human Factors and Usability Engineering to Medical Device, was conducted.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a sense of community and care.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 8, 2017
Shenzhen Dongdixin Technology Co., Ltd. Truman Shen R.A. Specialist No. 3 Building Xilibaimang Xusheng Industrial Estate Nanshan Shenzhen, 518108 CN
Re: K162479
Trade/Device Name: Smart Pain Reliever, Model LT5019 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: August 15, 2016 Received: January 9, 2017
Dear Truman Shen:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K162479
Device Name Smart Pain Reliever Model: LT5019
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)
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."
FORM FDA 3881 (8/14)
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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, with the exception of a yellow line that crosses through the "X" in "DIXIN". To the right of the English text is the company name in Chinese.
510(k) SUMMARY
as required by section 21 CFR 807.92
Smart Pain Reliever
| Date of Submission: 08/15/2016 |
|---|
| Submitter's Name: Shenzhen Dongdixin Technology Co., Ltd |
| Address: No. 3 Building, Xilibaimang Xusheng Industrial |
| Estate Nanshan, Shenzhen, CHINA 518108 |
| E-mail: shenc@dundex.com |
| Tel: +86(755) 27652471 |
| FAX: +86(755) 27652674 |
| Contact: Truman Shen |
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Image /page/4/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, with the "X" in DONGDIXIN being orange. To the right of the English text is the company name in Chinese characters.
TECHNOLOGY CO., LTD.
| 1. | Proposed Device: | |
|---|---|---|
| Device classification Name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter | |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relie | |
| Regulation Medical Specialty: | Neurology | |
| Review Panel: | Neurology | |
| Regulation Number: | 882.5890 | |
| Product Code: | NUH | |
| Device Class: | II | |
| 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: | II | |
| Device classification Name: | Stimulator, Electrical, Transcutaneous, For Arthritis | |
| Regulation Description: | Transcutaneous electrical nerve stimulator for pain relie | |
| Regulation Medical Specialty: | Neurology | |
| Review Panel: | Neurology | |
| Regulation Number: | 882.5890 | |
| Product Code: | NYN | |
| Device Class: | II |
2. Predicate Device:
| No. | Legally Marketed Device: | 510(k) Number: | Manufacturer: |
|---|---|---|---|
| 1 | PulseRelief | K151035 | Philips Consumer Lifestyle |
| 2 | SmartRelief | K131159 | Chattem, Inc. |
| 3 | Compex® Sport Plus | ||
| "MASSAGE" program | K083140 | Compex S.A. |
3. Description of Proposed Device:
LT5019 is designed to be used at home, by adults of all genders.
Explanation of how the device functions:
The Smart Pain Reliever includes TENS, EMS (including MASSAGE Program). 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.
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 "X" in "DIXIN" stylized in orange. To the right of the English name is the company name in Chinese characters.
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 11 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 8 pre-set EMS programs with different pulse settings. In each program, the intensity of the pulse can be adjusted.
The Smart Pain Reliever device only have one massage program, and this 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 functions of the LT5019 device:
The Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table). 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).
| Control/Indicator | User interface | Function |
|---|---|---|
| On/off Button | Press button (when device is off) | Turn on the device |
| Press button (when device is on) | Turn off the device (at any time, before, during or after treatment ) | |
| LED indicator | off | Device off |
| Green flashing | It means that the device is in standby mode | |
| Orange continuous | It means in treating mode or the battery is being charging | |
| Orange flashing | It means that the device is in paused mode | |
| Green continuous | It means it has connected with APP or the battery is full when charging |
Table 1: Smart Pain Reliever device controls and indicators
4. Proposed Device Intended for Use Statement:
Device Name: Smart Pain Reliever, Model: LT5019
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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 orange, with the company name in English and Chinese. The English name is in a bold, sans-serif font, and the Chinese name is in a traditional font. The logo is simple and modern, and it is likely used on the company's website and marketing materials.
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.
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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 is in a sans-serif font. The logo is simple and modern.
5. Technological Characteristics and Substantial Equivalence
Both the LT5019 and Predicate Device utilize the application of 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 | | Remark | or Regulated
Voltage? | | | | | | | | | |
|---|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--------------|---------------------------------------------------|-------------------------------------|---------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|------------------------|---------------------|--------------|
| 1 | 510K# | K162479 | K151035 | K131159 | K083140 | -- | 10 | Software/Firmware
/Micro processor
Control? | | Yes | Yes | Yes | Yes | Same | |
| 2 | Device Name and
Model | Smart Pain Reliever
Mode: LT5019 | PulseRelief | SmartRelief | Compex® Sport
Plus
"MASSAGE"
program | -- | 11 | Automatic
Overload Trip | | Yes | Yes | No | No | SE
Note 2 | |
| 3 | Manufacturer | Dongdixin Technology Co.,
Ltd | Philips Consumer Lifestyle | Chattem, Inc. | Compex S.A. | -- | 12 | Automatic No
Load contact Trip | | Yes | Yes | No | Yes | SE
Note 2 | |
| 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 | The OTC TENS/EMS
stimulator PulseRelief 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 exerciseor
normal household work
activities. It should be applied to
normal, healthy, dry and
clean skin of adult patients,
and is to be used for
stimulate healthy muscles in | To be used for
temporary relief of pain
associated with sore and
aching muscles 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 | Compex® Sport
Plus is intended to
stimulate healthy
muscles in order to
improve or
facilitate muscle
performance. | Similar | 13 | Automatic Shut off | | Yes | Yes | Yes | Yes | Same | |
| | | | healthy muscles in order to
improve and facilitate muscle
performance. | order to improve
and facilitate muscle
performance. | muscle | | | 14 | User Override
Control? | | Yes
Power on/off button on the
device, and power on/off in
the APP software | Yes
Power on/off button on the
device, and power on/off in
the APP software | No | Power on/off button | SE
Note 2 |
| 5 | Power Source | | 3.7V battery supply | 3.7V battery supply | 3V battery supply | NIMH rechargeable
battery (4.8V≥
1200mA/h) (4cells
pack of 1.2V ) | SE
Note 1 | 15 | Indicator
Display: | On/Off
Status? | Yes | Yes | Yes | Yes | Same |
| | -Method of Line
current isolation | | N/A | N/A | N/A | N/A | Same | | | Low
Battery? | Yes | Yes | No | Yes | SE
Note 2 |
| | - Patient Leakage
Current (μΑ) | | | | | | SE
Note 1 | | | Voltage/Current
Level? | Yes | Yes | Active/inactive output | Yes | SE
Note 2 |
| | -Normal
condition
-Single fault
condition | | 0uA
2.0uA |