(60 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a standard TENS device based on electrical stimulation, with no mention of adaptive algorithms or data processing that would indicate AI/ML.
Yes
The device is intended for the treatment and relief of nausea and vomiting, which are considered therapeutic purposes.
No
The device is described as a "wearable device for the treatment of nausea and vomiting," and its function involves providing "relief of nausea and vomiting through electrical stimulation of the median nerve." Its purpose is therapeutic, not to diagnose a condition.
No
The device description explicitly states it is a "wearable device" with a "Rubber wristband with two electrodes" that provide "electrical stimulation," indicating it is a hardware device with a physical component that delivers therapy. While it mentions "Software verification & validation," this is likely for the control system of the hardware, not a standalone software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is intended for the treatment of nausea and vomiting caused by motion sickness and pregnancy. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a wearable TENS (Transcutaneous Electrical Nerve Stimulation) device that applies electrical stimulation to the wrist. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), reagents, or diagnostic procedures.
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
TENS device-EmeTerm 2 is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
Product codes
GZJ
Device Description
TENS device-EmeTerm 2 is a single-patient use wearable device, rechargeable, non-invasive device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over-thecounter use in the relief of mild to moderate nausea and vomiting, motion sickness, mild to moderate nausea and vomiting associated with pregnancy.
TENS device-EmeTerm 2 includes a Rubber wristband with two electrodes must be placed at the center of the inner wrist, about 2 to 3cm from the wrist crease. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Clinical test:
Clinical testing is not required.
Non-clinical data:
The subject device performed:
Safety and Performance:
IEC 60601-1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 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
IEC 60601-2-10:2015 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
EMC:
IEC 60601-1-2 :2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests
Biocompatibility:
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro 1.
2. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Software verification & validation:
Guidance for the Content of Premarket Submissions for Software Contained in Medical Device
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
April 23, 2022
Joe Xu QA WAT Medical Technology Inc. Room703-711, No.2 North Taoyuan Road Ningbo, Zhejiang 315600 China
Re: K220503
Trade/Device Name: TENS device-EmeTerm 2, Model: YF-ZTY-E2 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 11, 2022 Received: February 22, 2022
Dear Joe Xu:
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 Scott Assistant Director, Neuromodulation Psychiatry Devices 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
2
Indications for Use
510(k) Number (if known) K220503
Device Name
TENS device-EmeTerm 2, Model: YF-ZTY-E2
Indications for Use (Describe)
TENS device-EmeTerm 2 is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: April 23, 2022
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | WAT Medical Technology Inc. |
|---|---|
| Address: | Room703-711, No.2 North Taoyuan Road, 315600, Ningbo, |
| Zhejiang Province, P.R.C | |
| Contact person: | Joe Xu |
| E-mail: | joexu@watmedical.com |
| Tel: | +86 151 6268 2168 |
2. Device Identification
| Trade/Device Name: | TENS device-EmeTerm 2 |
|---|---|
| Models: | YF-ZTY-E2 |
| Common name: | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation Number: | 21 CFR 882.5890 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator For Pain Relief |
| Regulation Class: | Class II |
| Panel: | Neurology |
| Product Code: | GZJ |
3. Predicate Device
| 510(K) number: | K172478 |
|---|---|
| Device Name: | TENS device-EmeTerm |
| Manufacturer: | YF-ZTY-E1 |
| Common name | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation Number: | 21 CFR 882.5890 |
| Regulation Name: | Transcutaneous Electrical Nerve Stimulator For Pain Relief |
| Regulation Class: | Class II |
| Panel: | Neurology |
|---|---|
| Product Code: | GZJ |
4
4. Device Description
TENS device-EmeTerm 2 is a single-patient use wearable device, rechargeable, non-invasive device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over-thecounter use in the relief of mild to moderate nausea and vomiting, motion sickness, mild to moderate nausea and vomiting associated with pregnancy.
TENS device-EmeTerm 2 includes a Rubber wristband with two electrodes must be placed at the center of the inner wrist, about 2 to 3cm from the wrist crease. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
5. Indication for use
TENS device-EmeTerm 2 is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
6. Technological Characteristics Comparison
Compared to the predicate device, the subject device has the same intended use, similar product design, and similar performance as the predicate device, the main differences of the proposed TENS device-EmeTerm 2 and device EmeTerm would be appearance, external form, electrode surface and power supply method. the summarized comparison information is listed in the following table:
| SE
Comparisons | Subject Device | Predicate Device
K172478 | Similarities/
Differences |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Device name,
Model | TENS device-EmeTerm 2
Model: YF-ZTY-E2 | TENS device-EmeTerm
Model: YF-ZTY-E1 | N/A |
| Manufacturer | WAT Medical Technology
Inc. | WAT Medical Technology Inc. | N/A |
| Classification | Class II | Class II | Same |
| Product code | GZJ | GZJ | Same |
| Indication for use | TENS device-EmeTerm 2 is
a wearable device for the
treatment of nausea and
vomiting caused by motion
sickness and pregnancy. | TENS device-EmeTerm is a
wearable device for the
treatment of nausea and
vomiting caused by motion
sickness and pregnancy. | Same |
5
| Power source | Rechargeable 3.7V DC. 80mAh Lithium battery | 3.7V DC. 140mAh Lithium battery | Note No.1 | |
|---|---|---|---|---|
| Follow Current | Yes | Yes | Same | |
| Voltage Overload Detection | Yes | Yes | Same | |
| Adjustable Intensity | 5 | 5 | Same | |
| Channel | 9 | 1 | Note No.2 | |
| Operati on Tips | Start | Yes | Yes | Same |
| Low Battery | Yes | Yes | Same | |
| Work | Yes | Yes | Same | |
| User Control | Touch screen and one home button | ON/OFF button on front of device | Note No.3 | |
| Patient override control method | Click the touch screen to enter the electric stimulation mode. It can be adjusted gears by swiping up or down. | On/Off and gear adjust button on front of device | Note No.4 | |
| Indicator displays | Screen | Unit functioning | ||
| Electrical connection | Note No.5 | |||
| Timer Setting | Yes | Yes | Same | |
| Waveform | AC Sharp Wave | AC Sharp Wave | Same | |
| Pulse width | 100 us (±10%) | 100 us (±10%) | Same | |
| Pulse period | 500 us (±10%) | 500 us (±10%) | Same | |
| Frequency (Hz) | 33Hz (±3Hz) | 33Hz (±0.5%) | Same | |
| Maximum output voltage (V): | ||||
| @1000 ohms | 39V (±3V ) | 38.2V (±0.5%) | Note No.6 | |
| Maximum output current (mA): | ||||
| @1000 ohms | 6mA root mean square value of the current (Irms); 40mA peak current. | 6mA root mean square value of the current (Irms); 40mA peak current. | Same | |
| Stimulating Surface Areas | 2.6 | 2.709 | Note No.7 | |
| (cm²) | ||||
| Maximum phase | ||||
| charge (µC) | ||||
| @1000Ω | 1.8 | 1.78 | Note No.8 | |
| Maximum | ||||
| Current Density, | ||||
| (mA/cm², r.m.s.) | ||||
| @1000Ω | 4.30 | 4.30 | Same | |
| Maximum | ||||
| Average Power | ||||
| Density, (W/cm²) | ||||
| @1000Ω | 0.00002 | 0.00002 | Same | |
| Maximum | ||||
| Average Current | ||||
| (average | ||||
| absolute value, | ||||
| mA) @1000Ω | 0.5 | 0.5 | Same | |
| Maximum | ||||
| Charge Density | ||||
| (uC/ cm²) | ||||
| @1000Ω | 1.3 | 1.28 | Note No.9 | |
| Net Charge (µC) | ||||
| per pulse | 0 | 0 | Same |
6
Note No. 1 The battery is different, we have performed testing on battery according to IEC 62133, the difference between two batteries will not affect the safety and effectiveness of the product.
- Note No. 2 The two products have the same core part. Emeterm 2 only adds 8 personal computer interaction interfaces, and Emeterm 2 has been validated performance, the results show that the difference will not affect the security and effectiveness of the product.
- Note No. 3 The difference of control methods will not affect the safety and effectiveness of the product.
- The difference of control methods will not affect the safety and effectiveness of the Note No. 4 product.
- Note No. 5 The difference of Indicator displays will not affect the safety and effectiveness of the product.
7
- 3% difference couldn't have effect on the product's function, also testing has been Note No.6 done in order to prove that the 1% differences will not affect the safety and effectiveness of our products.
- Note No.7 Different dimensions caused by different product design, which will not affect the device's safety and effectiveness.
- Note No.8 1% difference couldn't have effect on the product's function, also testing has been done in order to prove that the 1% differences will not affect the safety and effectiveness of our products.
- Note No.9 1% difference couldn't have effect on the product's function, also testing has been done in order to prove that the 1% differences will not affect the safety and effectiveness of our products.
7. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The subject device performed:
Safety and Performance:
IEC 60601-1:2012 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
IEC 60601-1-11:2015 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
IEC 60601-2-10:2015 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
EMC:
IEC 60601-1-2 :2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances -Requirements and tests
Biocompatibility:
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro 1.
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Software verification & validation:
Guidance for the Content of Premarket Submissions for Software Contained in Medical Device
8
8. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the Predicate device (K172478).