(53 days)
No
The document describes a standard TENS/EMS device with various modes and features, but there is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles (TENS mode) and to stimulate healthy muscles to improve performance (EMS mode), both of which are therapeutic purposes.
No.
The device's intended use is for temporary pain relief and muscle stimulation, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly mentions hardware components such as a main unit, LCD display, and battery power, and the performance studies include testing of electrical output and compliance with hardware-related standards (IEC 60601 series).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for temporary relief of pain and to stimulate muscles by applying electrical current to the body. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics and functionality of an electrical stimulator, not on analyzing samples from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device operates externally on the body to provide therapeutic benefits.
N/A
Intended Use / Indications for Use
TENS (Mode 1~6)
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.
EMS (Mode 1~6)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
Product codes
NUH, NGX
Device Description
1)Stylish appearance, compact size, humanized design for easy portability.
2)TENS and EMS modes with 6 different modes each, catering to various treatment needs and a wider range of users.
3)Dual-channel output, allowing control of intensity for each channel.
4)Unique combination of electric pulses for a different sensory experience.
5)LCD display for clear and easy use.
6)Powered by three AAA batteries (size 7), providing long-lasting usage and convenient for home and travel use.
7) The electrode patches used with the device are previously cleared under K221589 for safety use. The main unit delivers the electrical
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, back of the neck, arm, leg, and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 testing has 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 devices. The testing results demonstrate that the subject device complies with the following standards:
- IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipments 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 basic safety and essential performance -- Collateral standard: Requirements for medical electrical electrical systems used in the home healthcare environment
- IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The body-contacting components of this device are electrode patches the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K221589 and been marketed to US market. The electrode patches comply with the following standards:
- ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitroCytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Software verification and validation test was conducted 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 Document for Powered Muscle Stimulator 510(k)s".
The clinical test is not applicable, there is no clinical data.
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
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.
March 22, 2024
Hong Kong Etech Groups Limited % Rilev Chen RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K240292
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator (9029SCM) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: January 31, 2024 Received: February 1, 2024
Dear Riley Chen:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Tushar Bansal -S
for Heather Dean, PhD
Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Transcutaneous Electrical Nerve Stimulator (9029SCM)
Indications for Use (Describe)
TENS (Mode 1~6)
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.
EMS (Mode 1~6)
It is intended to 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)
X 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."
4
| 510(k) #: K240292 | 510(k) Summary | Prepared on: 2024-03-22 | |
|---|---|---|---|
| Contact Details | |||
| 21 CFR 807.92(a)(1) | |||
| Applicant Name | HONG KONG ETECH GROUPS LIMITED | ||
| Applicant Address | RM 747,7/F STAR HSE 3 SALISBURY RD TST Hong Kong Hong Kong | ||
| 999077 China | |||
| Applicant Contact Telephone | +86159197487099 | ||
| Applicant Contact | Ms. Haixin Chen | ||
| Applicant Contact Email | chinaetech65@etechgroups.com | ||
| Correspondent Name | Feiying Drug & Medical Consulting Technical Service Group | ||
| Correspondent Address | Rm 2401 Zhenye International Business Center, No. 3101-90, | ||
| Qianhai Road Shenzhen Guangdong 518052 China | |||
| Correspondent Contact Telephone | +86 13660660449 | ||
| Correspondent Contact | Ms. Riley Chen | ||
| Correspondent Contact Email | c3714930@gmail.com | ||
| Device Name | |||
| 21 CFR 807.92(a)(2) | |||
| Device Trade Name | Transcutaneous Electrical Nerve Stimulator (9029SCM) | ||
| Common Name | Transcutaneous electrical nerve stimulator for pain relief | ||
| Classification Name | Stimulator, Nerve, Transcutaneous, Over-The-Counter | ||
| Regulation Number | 882.5890 | ||
| Product Code(s) | NUH, NGX | ||
| Legally Marketed Predicate Devices | |||
| 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K191982 | Low-frequency Multi-function physiotherapy instrument | NUH | |
| K133929 | Health Expert Electronic Stimulator, Model: AST-300C and AST+ | NUH | |
| Device Description Summary | |||
| 21 CFR 807.92(a)(4) | |||
| 1)Stylish appearance, compact size, humanized design for easy portability. | |||
| 2)TENS and EMS modes with 6 different modes each, catering to various treatment needs and a wider range of users. | |||
| 3)Dual-channel output, allowing control of intensity for each channel. | |||
| 4)Unique combination of electric pulses for a different sensory experience. | |||
| 5)LCD display for clear and easy use. | |||
| 6)Powered by three AAA batteries (size 7), providing long-lasting usage and convenient for home and travel use. |
- The electrode patches used with the device are previously cleared under K221589 for safety use. The main unit delivers the electrical | | | |
5
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
TENS (Mode 1~6)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve. EMS (Mode 1~6)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
Indications for Use Comparison
The subject device and predicate devices have the same indications for use.
Technological Comparison
The technical characteristics of Transcutaneous Electrical Nerve Stimulator (Model:9029SCM) are substantially equivalent to the predicate devices in the following aspects:
-
the same intended use: both use electrical stimulation to temporary relief of pain under TENS mode and facilitate musce performance by using EMS mode.
-
operate with the same mode of action: the device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin to the underlying peripheral nerves and muscle.
-
the same design: two output channel for voltage controly, which can be adjusted separately, and also design with display screen for treatment parameters display.
-
similar output parameters, such as Maximum Output Current, Pulse frequency, Maximum Phase Charge, Maximum Average Current, Maximum Current Density(t.m.s.), and Maximum Average Power Density. The product waveform parameters were tested according to FDA guidance documents and the requirements of IEC 60601-2-10, the tests are all passed.
-
the same waveform and shape: biphasic symmetric square wave, rectangular
-
the same safety features: Type BF applied part.
-
the same housing materials: ABS plastic for main unit.
-
similar enrgy source as the primary predicate device: both use three AAA batteries (4.5V DC), and they all pass electrical safety test.
The difference between subject device and the predicate devices mainly includes the following:
-
The numbers of output modes (12 modes) and the output intensity level (18 gears) are different from those of the predicate devices (50 modes and 16 steps for K191982, 25 modes and 99 steps for K133929), but the output parameters of each mode were tested and found to be similar with the predicate devices, and the subject device has passed IEC 60601-2-10 test, so these differences do not lead to safety and effectiveness problems.
-
The weight (main unit: 11.5g) and dimensions (108.5x33.8x67.5mm) of the subject device are different from the predicate devices, but these differences are insignificant and will not affect the safety and effectiveness of the device.
Thus, the subject device is determined to be substantially equivalent to the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Nor-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 devices. The testing results demonstrate that the subject device complies with the following standards:
网 IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance മ IEC 60601-1-2, Medical electrical equipments for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
| EC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical electrical systems used in the home healthcare environment മ IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The body-contacting components of this device are electrode patches the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K221589 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. இ ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitroCytotoxicity
図SO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
6
We have also conducted:
l 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 Document for Powered Muscle Stimulator 510(k)s"
The clinical test is not applicable, there is no clinical data.
The subject device and predicate devices have indications for use, technological characteristics. The subject device is as safe, as effective and performs as well as the predicate devices.