(153 days)
No
The description details a standard TENS device with fixed modes and intensity levels controlled by manual buttons. There is no mention of adaptive algorithms, learning from user input, or any other characteristics indicative of AI/ML. The principle of operation describes basic electrical pulse generation and control.
Yes
The device is explicitly described as a "Transcutaneous electrical nerve stimulator" and its intended use is for "temporary relief of pain associated with sore and aching muscles," which places it under the definition of a therapeutic device designed to treat a medical condition (pain).
No
The device is described as a Transcutaneous electrical nerve stimulator for temporary pain relief. Its stated function is to provide low-frequency electronic therapy and heat for symptom relief, not to diagnose a medical condition.
No
The device description clearly outlines physical hardware components including a main unit, lithium battery, neck electrodes pads, control buttons, and a charging cable. It is a body-worn device that delivers electrical stimulation and heat through these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for temporary relief of pain in the neck muscles. It applies electrical pulses and heat to the skin.
- Lack of Sample Analysis: The device does not analyze any biological samples from the body. It directly interacts with the body's surface.
Therefore, this device falls under the category of a therapeutic device, specifically a TENS device, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
Product codes
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. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
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
adults
Intended User / Care Setting
home-use device
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)
FUTURE determined that bench and non-clinical testing were sufficient to demonstrate that Transcutaneous Electrical Nerve Stimulator, model: ST-304 is as safe and effective as the predicate device.
The recognized consensus standards for safety of medical equipment: ANSI AAMI ES60601-1, ANSI AAMI HA 60601-1-11 and for safety, IEC 60601-1-2 for electromagnetic compatibility, ISO 10993-5 and ISO 10993-10 for material biological compatibility, IEC 60601-2-10 for performance and IEC 62304 are complied.
Software verification and validation was performed for the subject device with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
The Output Waveform test was performed for the subject device with Guidance Document for Powered Muscle Stimulator 510(k)s.
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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September 13, 2022
Shenzhen Future Electronic Co., Ltd % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM. 1711, Building K, No. 101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K221092
Trade/Device Name: Transcutaneous Electrical Nerve Stimulator Model: ST-304 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: August 12, 2022 Received: August 12, 2022
Dear You Yijie:
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
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 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,
Pamela D. 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)
K221092 Device Name
Transcutaneous Electrical Nerve Stimulator Model: ST-304
Indications for Use (Describe)
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
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
1. Submitter's Information
Establishment Registration Information
Name: SHENZHEN FUTURE ELECTRONIC CO.,LTD Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116 Registration Number: 3014344342
Contact Person of applicant
Name: Zhao Qihong Address: Bldg B. Qiangchengda Industrial Park, No. 30, Youtian Road, Longgang SHENZHEN Guangdong, CN 518116 TEL: +86-134 1094 7296 FAX: +86-134 1094 7296 Email: zhaoqihong@futuresz.com.cn
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, No.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date prepared: Mar. 4, 2022
2. Device Information
| Trade Name: | Transcutaneous
stimulator | electrical | nerve |
|--------------------|---------------------------------------------------------|------------|-------|
| Model: | ST-304 | | |
| Regulation name: | Stimulator, Nerve, Transcutaneous, Over-
The-Counter | | |
| Review Panel: | Neurology | | |
| Product Code: | NUH | | |
| Regulation Class: | II | | |
| Regulation Number: | 21CFR 882.5890 | | |
3. Predicate Device Information
Primary Predicate Device
4
| 510(k) submitter/holder: | Shenzhen OSTO Technology Company Limited |
|---|---|
| 510(K) Number: | K210756 |
| Trade Name: | Neck Care Therapy |
| Model: | AST-905H |
| Classification name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Review panel: | Neurology |
| Product code: | NUH |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 882.5890 |
Secondary Predicate Device
| 510(k) submitter/holder: | Shenzhen OSTO Technology Company Limited |
|---|---|
| 510(K) Number: | K172897 |
| Trade Name: | Neck Care Therapy |
| Model: | 905B |
| Classification name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter |
| Review panel: | Neurology |
| Product code: | NUH, NGX |
| Regulation Class: | II |
| Regulation Number: | 21 CFR 882.5890, 890.5850 |
4. 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. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2:
| Titanium material (Gr.2) | Value |
|---|---|
| -------------------------- | ------- |
| Content | |
|---|---|
| Main Components | Ti |
| Remainder |
5
| Al | / | ||||
|---|---|---|---|---|---|
| V | / | ||||
| Impurity Elements | Fe | 0.235 | |||
| C | 0.008 | ||||
| N | 0.012 | ||||
| O | 0.130 | ||||
| H | 0.0043 | ||||
| Other Impurities | each | ≤ 0.1 | total | ≤ 0.3 |
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The following power adapter is recommended:
Manufacturer: ShenZhen RiHuiDa Power Supply Co., Ltd
Model: RHD 10W050100U
UL certificate: E474213 Specification: Input: 100-240V ~, 50/60Hz,0.7A Output :5V = 1000mA
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for
heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a
warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
Button function description:
6
Switch on/off button/mode switch button(
-
- Long press about (2 seconds) to turn on or turn off the Transcutaneous electrical nerve stimulator (model: ST-304) and sound "Di". When turn on the device or in the working condition the button indicator light is blue and turn off the device button indicator will close.
-
- When battery is low capacity(