(90 days)
No
The summary describes a standard TENS/EMS device with fixed modes and manual controls, and there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as a pain management device used for temporary relief of pain associated with sore and aching muscles and for symptomatic relief and management of chronic pain, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as a pain management device used for symptomatic relief, muscle performance improvement, and increased blood circulation by applying electrical stimulation. It does not mention any function related to diagnosing diseases or conditions.
No
The device description explicitly mentions physical components like electrode pads, electrode wire, a main unit with operating elements (knobs, buttons, dials), and states that accessories are purchased separately. It also details performance testing on the "final, finished product" which includes hardware. While software verification and validation are mentioned, the device is clearly a hardware-based TENS/EMS unit with integrated software for control, not a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The TENS & EMS Device described applies electrical stimulation to the body's surface for pain relief and muscle stimulation. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states the device is for temporary pain relief and muscle stimulation by applying current to the body. This is an external application, not an in vitro analysis.
Therefore, this device falls under the category of a therapeutic or physical medicine device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
-
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
-
To stimulate healthy muscles in order to improve and facilitate muscle performance .
-
To temporarily increase local blood circulation in healthy muscles.
Product codes
NUH, NGX, NYN
Device Description
TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet)
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)
1) Performance Testing Summary
The TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04) has been evaluated the safety and performance by lab bench testing as following:
- General requirements for basic safety and essential performance: The test sample is the final, finished product. Model: LY-ET-01, LY-ET-02, LY-ET-04. Test Method/Applicable Standards: IEC 60601-1:2005/AMD1:2012/AMD2:2020. Acceptance criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Results: Pass.
- Electromagnetic disturbances: The test sample is the final, finished product. Model: LY-ET-01, LY-ET-02, LY-ET-04. Test Method/Applicable Standards: IEC 60601-1-2:2014+A1:2020. Acceptance criteria: No degradation of performance was found during test or Lower than limits of measurement. Results: Pass.
- Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment: The test sample is the final, finished product. Model: LY-ET-01, LY-ET-02, LY-ET-04. Test Method/Applicable Standards: IEC 60601-1-11:2015/AMD1:2020. Acceptance criteria: The device operates normally, and can provide basic safety and essential performance. Results: Pass.
- Particular requirements for the basic safety and essential performance of nerve and muscle stimulators: The test sample is the final, finished product. Model: LY-ET-01, LY-ET-02, LY-ET-04. Test Method/Applicable Standards: IEC 60601-1-10 Edition 1.2 2020-07. Acceptance criteria: The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. Results: Pass.
2) Biocompatibility testing
- ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management.
- ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10:2010 Third Edition 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
3) Usability Testing
Usability testing was conducted on the TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04), the device complies with IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION Medical device- Part 1: Application of usability and IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION Medical electrical equipment-Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability.
4) 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 concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
5) Cybersecurity
The subject device no any external interfaces, according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", no need cybersecurity evaluation.
8.2 Clinical Performance
Clinical testing was not performed on the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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May 22, 2023
Jiangxi Royall Smart Technology Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong China
Re: K230443
Trade/Device Name: TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) 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: February 21, 2023 Received: February 21, 2023
Dear Cassie Lee:
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.
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
1
542 of the Act); 21 CFR 1000-1050.
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-
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 medical devices and radiation-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,
Robert Kang -S
for 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230443
Device Name
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04)
Indications for Use (Describe)
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
-
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
-
To stimulate healthy muscles in order to improve and facilitate muscle performance .
-
To temporarily increase local blood circulation in healthy muscles.
| 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 of K230443
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.
1. Submitter's Information
Sponsor Name: Jiangxi Royall Smart Technology Co., Ltd. Establishment Registration Number: Applying Address: Workshop 3#, Shangyou Lefeng Technology Co., Ltd., Huangbu Town, Ganzhou City, Jiangxi Province Postal code: 341200 Contact Person (including title): Shunzhou Yang (Head of Quality Division) Tel: +86 13421375258 Fax: / E-mail: shunzhou.yang@lefengmotors.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com
2. Date of the summary prepared: May 18, 2023
3. Subject Device Information
Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Trade Name: TENS & EMS Device Model Name: LY-ET-01, LY-ET-02, LY-ET-04 510(K) Number: K230443 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Regulation Number: 882.5890 Regulatory Class: II
4
4. Predicate Device Information
Predicate Device: Sponsor: Guangzhou Xinbo Electronic Co., Ltd. Trade Name: Pain Therapy Device, Models: P.T.S-II, P.T.S-IIA, P.T.S-IIB, CP-I Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K163611 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN Requlation Number: 21 CRF 882.5890
Requlation Class: II
Reference device:
Sponsor: Counter Scientific Development (GZ) Ltd Trade/Device Name: Pain Therapy System, Model PTS-II Common Name: TENS, EMS, Stimulator for pain relief Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter 510(K) Number: K150277 Review Panel: Neurology Product Code: Primary product code: NUH Secondary product code: NGX, NYN GZJ Regulation Number: 21 CRF 882.5890 Regulatory Class: II
5. Device Description
TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The
5
TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.
6. Intended Use / Indications for Use
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
- To be used for temporary relief of pain associated with sore and aching muscles in the upper and । lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- To stimulate healthy muscles in order to improve and facilitate muscle performance. -
- -To temporarily increase local blood circulation in healthy muscles.
7. Comparison to predicate device and conclusion
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Reference device | Remark | |
|---|---|---|---|---|---|
| Company | Jiangxi Royall Smart | ||||
| Technology Co., Ltd. | Guangzhou Xinbo | ||||
| Electronic Co., Ltd. | Counter Scientific | ||||
| Development (GZ) Ltd | -- | ||||
| Trade Name | TENS & EMS Device | Pain Therapy Device, | Pain Therapy System | -- | |
| 510(k) Number | K230443 | K163611 | K150277 | -- | |
| Classification | |||||
| Name | Transcutaneous | ||||
| Electrical Nerve | |||||
| Stimulator For Pain | |||||
| Relief, Over The | |||||
| Counter | Transcutaneous | ||||
| Electrical Nerve | |||||
| Stimulator For Pain | |||||
| Relief, Over The | |||||
| Counter | Transcutaneous | ||||
| Electrical Nerve | |||||
| Stimulator For Pain | |||||
| Relief, Over The | |||||
| Counter | Same | ||||
| Classification | |||||
| Product Code | NUH | NUH | NUH | Same | |
| Subsequent | |||||
| Product Code | NYN, NGX | NYN, NGX | GZJ, NGX, NYN | Same | |
| Elements of | Subject Device | Predicate Device | Reference device | Remark | |
| Comparison | |||||
| Intended Use / | |||||
| Indications for Use | TENS & EMS Device ( | ||||
| Model: LY-ET-01, LY-E | |||||
| T-02, LY-ET-04): |
- To be used for tempor
ary relief of pain associ
ated with sore and achi
ng muscles in the upper
and lower back, back o
f the neck, upper extre
mities (shoulder and ar
m), lower extremities (le
g and feet) due to strain
from exercise or norma
l household work activiti
es by applying current t
o stimulate nerve. To be
used for symptomatic r
elief and management o
f chronic, intractable pai
n and relief of pain asso
ciated with arthritis. - To stimulate healthy m
uscles in order to impro
ve and facilitate muscle
performance . - To temporarily increas
e local blood circulation
in healthy muscles. | To be used for
temporary relief of pain
associated with sore
and aching muscles in
the upper and lower
back, back of the neck,
upper extremities
(shoulder and arm),
lower extremities (leg
and feet) due to strain
from exercise or normal
household work
activities by applying
current to stimulate
nerve. To be used for
symptomatic relief and
management of chronic,
intractable pain and
relief of pain associated
with arthritis (Choose
Mode B or C).
To stimulate healthy
muscles in order to
improve and facilitate
muscle performance
(Choose Mode A).
To temporarily increase
local blood circulation in
healthy muscles
(Choose Mode A). | To be used for
temporary relief of pain
associated with sore
and aching muscles in
the upper and lower
back due to strain from
exercise or normal
household work
activities (Choose
Mode A, B, or C)
To be used for
temporary relief of pain
associated with sore
and aching muscles in
the upper extremities
(Arms) due to strain
from exercise or normal
household work
activities (Choose
Mode A, B or C)
To be used for
temporary relief of pain
associated with sore
and aching muscles in
the lower extremities
(Legs) due to strain
from exercise or normal
household work
activities (Choose
Mode A, B or C)
To be used for
symptomatic relief and
management of
chronic, intractable pain
and relief of pain
associated with Arthritis
(Choose Mode A)
To stimulate healthy
muscles in order to
improve and facilitate
muscle performance
(Choose Mode B) | Same |
| Regulatory Class | | Class II | Class II | Class II | Same |
| OTC or Rx | | OTC | OTC | OTC | Same |
| Power Source(s) | | DC 3.0V, 2 x AAA | DC 3.0V, 2 x AAA | DC 3.0V, 2 x AAA | Same |
| Method of Line
Current Isolation | | Type BF Applied Part | Type BF Applied Part | Use resistance to
isolate | Same |
| Patient
Leakage
Current | NC
SFC | DC: