(246 days)
No
The description focuses on basic electronic pulse generation and user-selectable modes/intensity, with no mention of adaptive algorithms, learning, or data processing beyond simple display.
Yes
The device is a therapeutic device because its intended use is for the temporary relief of pain associated with sore and aching muscles.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator used for temporary pain relief, which is a therapeutic function, not a diagnostic one. It does not mention any function for identifying or analyzing medical conditions.
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 software verification and validation were conducted, this is standard for medical devices with embedded software, not indicative of a software-only device.
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 of pain associated with sore and aching muscles. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description clearly states it's a Transcutaneous Electrical Nerve Stimulator (TENS) that delivers electric pulses to the skin. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.
IVD devices are used 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, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.
There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.
The Transcutaneous Electrical Nerve Stimulator 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 painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And 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, back, arm, leg, foot
Indicated Patient Age Range
Adult
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
Non-clinical testings have been conducted to verify that the Transcutaneous Electrical Nerve Stimulator 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 IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for A basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements A for the basic safety and essential performance of nerve and muscle stimulators
The body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. So we have reason to believe that the electrode patches are safe for the users. The electrode patches comply with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- A 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"
- 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
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 30. 2019
Shenzhen Kentro Medical Electronics Co., Ltd % Tracy Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No.22 Guimiao Rd. Shenzhen, 518000 Cn
Re: K183288
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (Models: KTR-206, KTR-208, KTR-209) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: June 3, 2019 Received: June 5, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183288
Device Name
Transcutaneous Electrical Nerve Stimulator (KTR-206, KTR-208, KTR-209)
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, arm, leg, 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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(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 | March 1, 2019 |
| prepared: | prepared: |
(2) Proprietary name of the device
| Trade name/model: | Transcutaneous Electrical Nerve Stimulator/ KTR-206,
KTR-208, KTR-209 |
|--------------------|--------------------------------------------------------------------------|
| Common name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Regulation number: | 21 CFR 882.5890 |
| Product code: | NUH |
| Review panel: | Neurology |
| Regulation class: | Class II |
(3) Predicate and reference devices
| * Predicate device | |
|---|---|
| Sponsor | Easymed Instruments Co., Ltd |
| Device Name and Model | EasyStim TN28_OTC |
| 510(k) Number | K140168 |
| Product Code | NUH |
| Regulation Number | 21 CFR 882.5890 |
| Regulation Class | II |
彩 Reference device
| Sponsor | Shenzhen
Technology
Limited | OSTO
Company | DJO, LLC | Omron Healthcare,
Inc. |
|---------|-----------------------------------|--------------------------|------------------|---------------------------|
| Device | Name | Health Expert Electronic | Compex® Wireless | Avail, Model |
4
| and Model | | Stimulator,
AST-300C
AST-300D | Model: USA
and | PM601 |
|-------------------|--|-------------------------------------|-------------------|-----------------|
| 510(k) Number | | K133929 | K170903 | K172079 |
| Product Code | | NUH, NGX | NUH, NGX, NYN | NUH, NYN |
| Regulation Number | | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 |
| Regulation Class | | II | II | II |
(4) Description/ Design of device:
Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.
There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.
The Transcutaneous Electrical Nerve Stimulator 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 painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And 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, back, arm, leg, foot, due to strain from exercise or normal household and work activities.
| Component name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Electrode patches | EVA foam, carbon | Surface skin contact | Less than 24 hours |
(6) Materials
5
film, hydrogel, PET
We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to US market. For details, please refer to "Biocompatibility Discussion".
(7) Technological characteristics and substantial equivalence:
| Item | Targeted
device | Predicate
device | Reference
device 1 | Reference
device 2 | Reference
device 3 | Remark |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Trade name | Transcutaneo
us Electrical
Nerve
Stimulator | EasyStim
TN28_OTC | Health Expert
Electronic
Stimulator,
Model:
AST-300C
and
AST-300D | Compex®
Wireless USA | Avail Model /
PM601 | / |
| 510
(k)
number | K183288 | K140168 | K133929 | K170903 | K172079 | / |
| Regulation
number | 21 CFR 882.
5890 | 21 CFR 882.
5890 | 21 CFR 882.
5890 | 21 CFR 882.
5890 | 21 CFR
882. 5890 | Same |
| Regulation
description | Transcutaneo
us electrical
nerve
stimulator for
pain relief | Transcutaneo
us electrical
nerve
stimulator for
pain relief | Transcutaneo
us electrical
nerve
stimulator for
pain relief | Transcutaneou
s electrical
nerve
stimulator for
pain relief | Transcutane
ous
Electrical
Nerve
Stimulator
For Pain
Relief | Same |
| Product
code | NUH | NUH | NUH, NGX | NUH,
NGX,
NYN | NUH, NYN | Same |
| Class | II | II | II | II | II | Same |
| Indications
for use/
Intended use | To be used
for temporary
relief of pain
associated
with sore and
aching
muscles in
the shoulder,
back, arm,
leg, foot, due
to strain from | This device is
intended
for the relief
of pain
associated
with sore or
aching
muscles of
the lower
back, arms,
or legs due to | TENS (Mode
9~25)
To be used
for temporary
relief of pain
associated
with sore and
aching
muscles in
the shoulder,
waist, back, | The Compex
Wireless USA
TENS is used
for:
• temporary
relief of pain
associated
with sore and
aching
muscles due to
strain from | The Avail is
intended for
the relief of
pain
associated
with sore or
aching
muscles of
the lower
back, arms,
legs, | Similar |
| | normal | exercise or | neck, arm, | normal | or feet due | |
| | household | normal | leg, and foot | household and | to strain | |
| | and work | household | due to strain | work | from | |
| | activities. | and work | from exercise | activities. | exercise or | |
| | | activities. | or normal | • the | normal | |
| | | | household | symptomatic | household | |
| | | | work | relief and | work | |
| | | | activities by | management | activities. | |
| | | | applying | of chronic, | When used | |
| | | | current to | intractable | for the | |
| | | | stimulate | pain and relief | symptomati | |
| | | | nerve. | of pain | c relief and | |
| | | | | associated | managemen | |
| | | | | with arthritis. | t of chronic, | |
| | | | | | intractable | |
| | | | | | pain and | |
| | | | | | relief of | |
| | | | | | pain | |
| | | | | | associated | |
| | | | | | with | |
| | | | | | arthritis, use | |
| | | | | | the Tap, | |
| | | | | | Shoulder, | |
| | | | | | Arm or Leg | |
| | | | | | mode of | |
| | | | | | stimulation. | |
| | | | | | Environmen | |
| | | | | | ts of Use: | |
| | | | | | Clinics, | |
| | | | | | hospital and | |
| | | | | | home | |
| | | | | | environment | |
| | | | | | S | |
| | | | | | Patient | |
| | | | | | Population: | |
| | | | | | Adult | |
| Patient | Adult | Adult | Adult | Adult | Adult | Same |
| population | | | | | | |
| Location for | OTC | OTC | OTC | OTC | OTC | Same |
| use | | | | | | |
| Basic unit specifications | | | | | | |
| Power | KTR-206:
2 | 2
Alkaline | Adaptor | Remote: | Rechargeabl | Similar |
| supply | AAA
batteries (DC | 1.5V
AA
(LR6) | Input:
100-240Vac, | Lithium
Polymer | e
Lithiumion | |
| | 3V) | Batteries | 50-60Hz, 0.1A
Output:5Vdc, 1A
Unit Input: 5Vdc,1A | (LiPo) rechargeable 3.7[V]/≥ 1500[mAh
Stimulation Modules:
Lithium Polymer (LiPo) rechargeable 3.7[V]/ ≥ 450[mAh] | battery | |
| | KTR-208: 2
AAA
batteries (DC 3V)
KTR-209:
AAA LR03
battery ×3
(DC 4.5V) | | | | | |
| Leakage
current | N/A (Battery
operated) | / | AC: 54.5μΑ,
DC: 0.5μA
(NC)/
AC:120.0μA,
DC: 0.6μΑ
(SFC) | N/A (Battery
operated) | Normal
Condition
(uA):
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
13
Based on the above analysis and tests performed, it can be concluded that the performance and function of Transcutaneous Electrical Nerve Stimulator are normal, and it is Substantially Equivalent (SE) to the predicate device.