(580 days)
Not Found
No
The description details a device with fixed modes, intensity levels, and heating function controlled by a remote. There is no mention of adaptive behavior, learning, or any components typically associated with AI/ML. The performance studies listed are standard electrical and safety tests, not AI/ML validation.
Yes
The device is described as "designed to temporarily relieve pain associated with sore and aching muscles" and uses "electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation," which indicates a therapeutic purpose. Additionally, it lists predicate devices that are also therapeutic in nature (e.g., "HIVOX OTC Electrical Stimulator", "Neck Care Therapy").
No
The device is designed for therapeutic purposes (pain relief, muscle stimulation, warming sensation) rather than for diagnosing a medical condition.
No
The device description clearly outlines physical hardware components including electrode pads, a heating element, and a remote control, in addition to the electrical stimulation functionality. The performance studies also include testing against hardware-specific standards (e.g., 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 is to "temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities." This describes a therapeutic or pain management function, not a diagnostic one.
- Device Description: The description details electrical stimulation and heating applied externally to the body. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a biological marker, or provide information about a patient's health status based on in vitro analysis.
In summary, the Smart Neck Stimulator is a therapeutic device for pain relief, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design.
The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity selected to increase or decrease, the " " button intends to turn the heating function on and the " Ho button intends to turn the heating function off.
The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
back of neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Smart Neck Stimulator has been evaluated the safety and performance by lab bench testing as following:
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance | 2005/(R)2012 And A1:2012, | 07/09/2014 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 60601-2-10 | Medical Electrical Equipment - Part 2- 10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators | Edition 2.1 2016-04 | 06/07/2018 |
| IEC 60601-1-11 | 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 | Edition 2.0 2015-01 | 06/27/2016 |
| IEC 62133-2 | Secondary Cells And Batteries Containing Alkaline Or Other Non-Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications - Part 2: Lithium Systems | Edition 1.0 2017-02 | 01/14/2019 |
| IEC 62366-1 | Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices | Edition 1.0 2015-02 | 12/23/2016 |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | Third Edition 2009-06-01 | 12/23/2016 |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Third Edition 2010-08-01 | 07/26/2016 |
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.
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 4, 2021
Guandong Skg Intelligent Technology Co., Ltd Fanny Yuan Manager No.1, 7/F. Yingfeng Business Center, No.8 Yixing Road, Beijiao Town Shunde District, Foshan City, Guandong Province 528303 China
Re: K200558
Trade/Device Name: Smart Neck Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: August 26, 2021 Received: September 1, 2021
Dear Fanny Yuan:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
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) K200558
Device Name Smart Neck Stimulator (Model: 4098 (RED))
Indications for Use (Describe)
The Smart Neck Stimulator is designed to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household 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 of K200558
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Submitter's Information 1.
- � Company Name: GUANGDONG SKG INTELLIGENT TECHNOLOGY CO., LTD
- Establishment Registration Number: Applying �
- Address: No.1, 7/F, Yingfeng Business Center, No.8 Yixing Road, Beijiao Town, Shunde District, � Foshan City, Guangdong Province, China
- � Postal Code: 528303
- � Phone: +86 18231193066
- � TEL: +86 40 0822 0888
- Contact Person (including title): Mao Hui Zhang (Certificated Engineer) �
- E-mail: zhangmaohui@skg.com �
2. Manufacturer
- Company Name: Guangdong Shiqi Manufacture Co., Ltd �
- � Address: D10-11, Lunjiao Intensive Industrial Zone, Licun Village Committee, Lunjiao Street Office, Shunde District, Foshan City, Guangdong Province, China
- Phone: +86 18231193066 �
- � Tel: +86 40 0822 0888
- Contact Person: Mao Hui Zhang �
3. Application Correspondent:
- � Company: Share Info (Guangzhou) Medical Consultant Ltd.
- � Contact Name: Ms. Fanny Yuan
- E-mail: medical-device@qq.com �
4. Subject Device Information
- Smart Neck Stimulator � Trade Name:
- Transcutaneous Electrical Nerve Stimulator for Pain Relief Common Name: �
- Stimulator, nerve, transcutaneous, over-the-counter � Classification name:
- Neurology, Physical Medicine Review Panel: �
- NUH Product Code: �
- ll � Regulation Class:
- 882.5890 Regulation Number: �
5. Predicate Device Information
4
| Sponsor | HIVOX BIOTEK INC. | Shenzhen OSTO Technology Co.,
Ltd. |
|--------------------------|---------------------------------|---------------------------------------|
| Device Name and
Model | HIVOX OTC Electrical Stimulator | Neck Care Therapy |
| 510(k) Number | K171803 | K172897 |
| Product Code | NUH, NGX | NUH, NGX |
| Regulation Number | 882.5890, 890.5850 | 882.5890, 890.5850 |
| Regulation Class | II | II |
6. Device Description
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design.
The device totally has 3 modes and each mode has 15 output Intensity Levels, so the device can give certain electrical pulse through the electrode pads on the skin to help users to enjoy back neck stimulation. It can also provide a constant temperature of 37°C to 41°C to provide a warming sensation. The subject device can be controlled by a remote control which based on the radiofrequency technology. There are 5 buttons in the remote control, the "M" button for modes selection, "+" or "-" button for intensity
selected to increase or decrease, the " "" button intends to turn the heating function on and the " Ho button intends to turn the heating function off.
The device can be turned on when both power button on subject device has been turned on and the treatment mode can be selected by the remote control.
7. Intended Use / Indications for Use
The Smart Neck Stimulator is designed to be used to temporarily relieve pain associated with sore and aching muscles in the back of neck due to strain from exercise or normal household work activities.
8. Test Summary
Smart Neck Stimulator has been evaluated the safety and performance by lab bench testing as following:
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: | ||
| General Requirements For Basic Safety | |||
| And Essential Performance | 2005/(R)2012 And | ||
| A1:2012, | 07/09/2014 | ||
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: | ||
| General requirements for basic safety | |||
| and essential performance - Collateral | |||
| standard: Electromagnetic compatibility |
- Requirements and tests | Edition 4.0 2014-02 | 09/17/2018 |
| IEC 60601-2-10 | Medical Electrical Equipment - Part 2-
10: Particular Requirements For The
Basic Safety And Essential
Performance Of Nerve And Muscle
Stimulators | Edition 2.1 2016-04 | 06/07/2018 |
5
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| IEC 60601-1-11 | 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 | Edition 2.0 2015-01 | 06/27/2016 | |
| IEC 62133-2 | Secondary Cells And Batteries | ||
| Containing Alkaline Or Other Non-Acid | |||
| Electrolytes - Safety Requirements For | |||
| Portable Sealed Secondary Cells, And | |||
| For Batteries Made From Them, For | |||
| Use In Portable Applications - Part 2: | |||
| Lithium Systems | Edition 1.0 2017-02 | 01/14/2019 | |
| IEC 62366-1 | Medical Devices - Part 1: Application Of | ||
| Usability Engineering To Medical | |||
| Devices | Edition 1.0 2015-02 | 12/23/2016 | |
| ISO 10993-5 | Biological evaluation of medical devices |
- Part 5: Tests for In Vitro cytotoxicity | Third Edition 2009-06-01 | 12/23/2016 |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin
sensitization | Third Edition 2010-08-01 | 07/26/2016 |
9. Comparison to predicate device and conclusion
The Smart Neck Stimulator has similar intended use, technological characteristics and same principle of operation as these predicate devices. Although there are several specifications different between these devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore the differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
|---|---|---|---|---|---|
| Company | GUANGDONG SKG | ||||
| INTELLIGENT | |||||
| TECHNOLOGY CO., LTD | HIVOX BIOTEK INC. | Shenzhen OSTO | |||
| Technology Co., Ltd. | -- | ||||
| Trade Name | Smart Neck Stimulator | HIVOX OTC Electrical | |||
| Stimulator | Neck Care Therapy | -- | |||
| Classification | |||||
| Name | Stimulator, nerve, | ||||
| transcutaneous, over-the- | |||||
| counter | Stimulator, nerve, | ||||
| transcutaneous, over- | |||||
| the-counter | Stimulator, nerve, | ||||
| transcutaneous, over- | |||||
| the-counter, | |||||
| Stimulator, Muscle, | |||||
| Powered, For Muscle | |||||
| Conditioning | -- | ||||
| 510(k) Number | K200558 | K171803 | K172897 | -- | |
| Elements of | |||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Product Code | NUH | NUH, NGX | NUH, NGX | SE | |
| Intended Use / | |||||
| Indications for | |||||
| Use | The Smart Neck | ||||
| Stimulator is designed to | |||||
| be used to temporarily | |||||
| relieve pain associated | |||||
| with sore and aching | |||||
| muscles in the back of | |||||
| neck due to strain from | |||||
| exercise or normal | |||||
| household work activities. | HIVOX OTC Electrical | ||||
| Stimulator, SEM44: | |||||
| 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), | |||||
| lower extremities | |||||
| (leg), abdomen and | |||||
| bottom due to strain | |||||
| from exercise or | |||||
| normal household | |||||
| work activities. | |||||
| EMS: The device is | |||||
| designed to be used | |||||
| for stimulate healthy | |||||
| muscles in order to | |||||
| improve and facilitate | |||||
| muscle performance. | |||||
| HIVOX OTC Electrical | |||||
| Stimulator, SEM44-1: | |||||
| 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), | |||||
| lower extremities | |||||
| (leg), abdomen and | |||||
| bottom due to strain | |||||
| from exercise or | |||||
| normal household | |||||
| work activities. | To be used for | ||||
| temporary relief of | |||||
| pain associated with | |||||
| sore and aching | |||||
| muscles in the | |||||
| shoulder, waist, back | |||||
| of neck, back, arm, | |||||
| and leg, due to strain | |||||
| from exercise or | |||||
| normal household | |||||
| and work activities. |
- Neck Pad is
used in back of neck. - Meridian Pad
is used in shoulder,
waist, back, and arm. | SE | |
| Type of use | OTC | OTC | OTC | SE | |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | |
| Power source | 3.7V, 1500mAh lithium
battery | 4.5V (batteries,
3x1.5V AAA) | For the power
adaptor:
Input: 100~240Vac
50/60Hz, 0.2A;
Output: 5Vdc, 1A
Unit Input: 5Vdc, 1A
For Battery: 3.7 Vdc,
500mAh
For Remote Control:
(2x1.5V AAA battery) | SE | |
| Method of Line
Current
Isolation | Type BF Applied Part | Not publicly available | Type BF Applied Part | SE | |
| Patient
Leakage
Current | NC | 50 μΑ | Not publicly available | AC: 54.5μΑ
DC: 0.5µA | SE |
| | SFC | 100 μΑ | Not publicly available | AC: 120μA
DC: 0.6μA | Note 2 |
| Average
current through
electrodes
when device is
on but no
pulses are
being applied |