(108 days)
No
The description focuses on basic electronic pulse generation and transmission, with user-selectable modes and intensity displayed on an LCD. There is no mention of adaptive algorithms, learning from data, or any other characteristics typically associated with AI/ML. The performance studies focus on electrical safety and waveform output, not AI/ML performance metrics.
Yes
The device is explicitly described as a "Low-Frequency Therapy Instrument" with the purpose of providing "temporary relief of pain associated with sore and aching muscles," which indicates a therapeutic intent and function.
No
The device description states it "produces low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves... in order to reach the therapeutic aim," indicating a treatment function, not a diagnostic one. Its intended use is for "temporary relief of pain."
No
The device description explicitly states it is composed of a "host and electrode patches" and uses "AAA batteries for power supply," indicating it is a hardware device that delivers electrical pulses. While it contains software for control and display, it is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the temporary relief of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device works by producing low-frequency electrical pulses and transmitting them through the skin to peripheral nerves. This is a physical therapy mechanism, not a method for examining specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a person's health status based on such analysis.
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 description.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.
There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.
The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, arm, leg and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests have been conducted to verify that the low-frequency therapy instrument meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:
- A IEC60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC60601-1-11, 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
- A IEC60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- A IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133929, K124055, K150386, K160893
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 11, 2017
Shenzhen Kentro Medical Electronics Co., Ltd Tracy Che Application Correspondent No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District Shenzhen City, 518115 CN
Re: K170205
Trade/Device Name: Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: April 24, 2017 Received: April 26, 2017
Dear Tracy Che:
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
1
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 (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,
William J. Heetderks -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) K170205
Device Name
Low-Frequency Therapy Instrument/Model: KTR-201, KTR-202, KTR-203
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K170205
(1) Applicant information:
| 510(k) owner's name: | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|---|---|
| Address: | No.3, Xihu Industry Zone, Xikeng Village, Henggang Town, |
| Longgang District, Shenzhen City, Guangdong Province, China | |
| Contact person: | Zewu Zhang |
| Phone number: | +86 755 3382 5998 |
| Fax number: | +86 755 3382 5996 |
| Email: | kentro@kentro.com.cn |
| Date of summary prepared: | May 4, 2017 |
(2) Proprietary name of the device
| Trade name/model: | Low-Frequency Therapy Instrument /Model: KTR-201,
KTR-202, KTR-203 |
|--------------------|-----------------------------------------------------------------------|
| Common name: | Transcutaneous Electrical Nerve Stimulator |
| Regulation number: | 21CFR 882.5890 |
| Product code: | NUH |
| Review panel: | Neurology |
| Regulation class: | Class II |
(3) Predicate devices
| Sponsor | Shenzhen OSTO
Technology
Company Limited | Endurance
Therapeutics | Tyece Ltd. | M.i.tech Co.,
Ltd. |
|--------------------------|------------------------------------------------------------------------------|---------------------------|------------------------------------------|-----------------------|
| Device Name
and Model | Health Expert
Electronic
Stimulator, Model
AST-300C and
AST-300D | T1040
Aurawave | Tyece OTC
TENS Device,
Model SEM44 | HANAROCare
ReJu |
| 510(k)
Number | K133929 | K124055 | K150386 | K160893 |
| Product
Code | NUH, NGX | NUH, NYN, NGX,
GZJ | NUH | NUH |
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR | 21 CFR |
4
| Number | 882.5890 | 882.5890 | ||
|---|---|---|---|---|
| Regulation | ||||
| Class | II | II | II | II |
(4) Description/ Design of device:
The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.
There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.
The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.
(5) Intended use / indications:
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and foot, due to strain from exercise or normal household and work activities.
(6) Materials
| Component name | Material of
Component | Body Contact
Category | Contact Duration |
|-------------------|--------------------------|--------------------------|--------------------|
| Electrode patches | Hydrogel | Surface skin contact | Less than 24 hours |
We have directly purchased electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K152815 and been legally marketed to US market. For details, please refer to "Biocompatibility Discussion".
(7) Technological characteristics and substantial equivalence:
| Parameters | Subject
(K170205) | device | Primary predicate
(K133929) | Remark |
|------------|----------------------|--------|--------------------------------|--------|
| Trade name | Low-Frequency | Health | Expert | N/A |
5
| | Therapy Instrument
(Model: KTR-201, KTR-202, KTR-203) | Electronic Stimulator,
Model: AST-300C and AST-300D | |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | To be used for temporary relief of pain associated with sore and aching
muscles in the shoulder, waist, back, arm, leg
and foot, due to strain from exercise or
normal household and work activities. | To be used for temporary relief of pain associated with sore and
aching
muscles in the shoulder, waist, back, back of
the neck, arm, leg,
and foot due to strain from
exercise or normal household work
activities by applying
current to
stimulate nerve. | Similar |
| Regulation number | 21 CFR 882.5890 | 21 CFR 882.5890 | Identical |
| Product code | NUH | NUH, NGX | Similar |
| Class | II | II | Identical |
| OTC/Rx | OTC | OTC | Identical |
| Basic unit specifications | | | |
| Power supply | KTR-201: DC 3V, 30 mA
KTR-202: DC 4.5V, 100 mA
KTR-203: DC 3V, 30mA | 100-240VAC, 50-60Hz, 0.1A | Predicate is
powered by mains
supply but does not
affect safety and
effectiveness of
subject device |
| Output modes | KTR-201: 10
KTR-202:10
KTR-203: 5 | 25 | Identical |
| Output channels | KTR-201: 1
KTR-202:1
KTR-203: 2 | 2 | Similar. Does not
affect safety and
effectiveness of
subject device. |
| Software | Yes | Yes | Identical |
| Automatic Shut off | Yes | Yes | Identical |
| Timer range | 15 mins | 25 mins | Different but does
not affect safety
and effectiveness
of subject device. |
| Dimensions | KTR-201: 147mm x
59mm x 27.5mm | 428mm x 428.8mm x
185mm | Not applicable |
| | 100mm x 46mm
KTR-203: 98.9mm x
64mm x 31.25mm | | |
| Weight | KTR-201 (Host): 2.7oz
KTR-202 (Host): 5.7oz
KTR-203 (Host): 1.7oz | 70.5oz (2kg) (without accessories) | Not applicable |
| Housing material
and construction | ABS | ABS | Identical |
| Compliance with
voluntary
standards | IEC60601-1;
IEC60601-1-2;
IEC60601-1-11;
IEC-60601-2-10 | IEC60601-1;
IEC60601-1-2;
IEC-60601-2-10;
ISO10993-5;
ISO10993-10 | Similar |
| Compliance with
21 CFR 898 | Yes | Yes | Identical |
| Output specifications | | | |
| Waveform | Pulsed symmetric, biphasic, square wave | Pulse symmetric, biphasic, rectangular
with interphase interval | Similar |
| Maximum output
voltage (Vp) | 44V@500ohm
58V@2kohm
63.5V@10kohm | 44V±10% @500ohm
80V±10% @2kohm
112V±10@10kohm | Similar |
| Maximum output
current | 88mA@500ohm
29mA@2kohm
6.35mA@10kohm | 88mA±10% @500ohm
40mA±10% @2kohm
11.2mA±10% @ 10kohm | Similar |
| Net charge (per
pulse) | 0µC @500ohm | 0µC @500ohm | Identical |
| Maximum phase
charge | 11.7µC @500ohm | 12.78μC@500ohm | Similar |
| Maximum Average
Current (500ohm) | 7.4mA | 0.968mA | Although the
maximum average
current is different,
it is ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
We have also conducted:
- A Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- A The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use
(9) Conclusion
Based on the above analysis and tests performed, it can be concluded that the performance and function of Low-Frequency Therapy Instrument are normal, safe and effective, and it is Substantially Equivalent (SE) to the predicate devices.