(107 days)
Not Found
No
The device description and performance studies do not mention any AI or ML capabilities. The functionality is described as generating fixed electrical pulses with selectable modes.
Yes
The device is described as an "Electronic Pulse Stimulator" used for "temporary relief of pain associated with sore and aching muscles" by delivering electric pulses, which directly indicates its therapeutic purpose.
No
Explanation: The device is described as an "Electronic Pulse Stimulator" intended for "temporary relief of pain associated with sore and aching muscles." Its function is to deliver electrical pulses to activate nerves and relieve pain, not to diagnose any condition.
No
The device description explicitly states it is powered by an internal battery, generates electric pulses, and delivers them through electrode pads. It also lists accessories including connecting wires, electrode pads, and batteries, all of which are hardware components. The performance studies also include electrical safety, EMC, and performance bench tests, which are relevant to hardware. While software verification and validation are mentioned, the device is clearly not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary relief of pain associated with sore and aching muscles." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device delivers electrical pulses to the skin to stimulate nerves and relieve pain. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, sample collection, or analysis of biological specimens.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for pain relief through electrical stimulation.
N/A
Intended Use / Indications for Use
The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and work activities.
Product codes
NUH
Device Description
The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit.
The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness.
Its accessories include connecting wires, electrode pads, 2 AAA batteries.
The device is for over the counter use.
The device does not contain drug or biological products.
The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, waist, back, upper extremities (leg)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
at home use / 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)
- Biocompatibility Testing: The material in contact with the patient of the proposed device is self adhesive electrode, which has been conducted the biocompatibility test according to the requirement of the ISO 10993-1, ISO 10993-5, ISO 10993-10.
- Electrical safety and electromagnetic compatibility (EMC) The proposed device Electronic Pulse Stimulator MDTS100 is tested in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 to evaluate the electrical safety and EMC.
- Performance Test-Bench: We have also conducted IEC 60601-2-10 and other performance tests including maximum output amplitudes, pulse durations, pulse repetition frequencies, maximum output current, supply voltage fluctuations, supply voltage fluctuations, Cleaning Test , High and Low Temperature & Humidity Test, Shelf-life Test as so on.
- 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 of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
- Cybersecurity testing: Cybersecurity testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Postmarket Management of Cybersecurity in Medical Devices." Cybersecurity testing was performed because of the Bluetooth function. Please note that the Bluetooth function in this model of the device is not used.
- Wireless Testing: We have conducted the FCC test and wireless coexistence for the proposed device MDTS 100. The test reports are presented in Electromagnetic Compatibility and Electrical Safety. Wireless testing was performed because of the Bluetooth function. Please note that the Bluetooth function in this model of the device is not used.
- Clinical Testing: The clinical testing was not needed in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 21, 2022
Beijing Choice Electronic Technology Co., Ltd. c/o Haiying Zhao Quality Director North Building 3F, No.9 Shuangyuan Road Badachu Hi-tech Zone, Shijingshan District Beijing, China 100041
Re: K221992
Trade/Device Name: Electronic Pulse Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: September 15, 2022 Received: September 19, 2022
Dear Haiying Zhao:
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,
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 Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K221992
Device Name Electronic Pulse Stimulator
Indications for Use (Describe)
The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and 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
Section II 510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.
There is no prior submission for the device.
3.1 Submitter Information
● Manufacturer Name:
Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. 2nd Floor, 3rd Floor and Room 410-412 4th Floor, No. 2 Building, No. 9 Shuangyuan Road , Shijingshan District BEIJING, 100041, P.R.China
● Contact Person:
Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88204631 Fax: 861088204632 Email: cc@choicemmed.com
- Date prepared :June 24, 2022 ●
3.2 Proposed Device Information
Device Common Name: Transcutaneous Electrical Nerve Stimulator, OTC
Device Trade/Proprietary Name: Electronic Pulse Stimulator
Model: MDTS100
Classification Name: Stimulator, Nerve, Transcutaneous,Over-The-Counter
Regulation Number: 882.5890
Product Code: NUH
Class: II
Panel: Neurology
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3.3 Predicate Device
510(k) Number: K160508
Common Name: Transcutaneous Electrical Nerve Stimulator, OTC
Device Trade/Proprietary Name: Electronic Pulse Stimulator
Model: MDTS100
Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter
Product Code: NUH
Regulation Number: 882.5890
Device Class: II
Panel: Neurology
Manufacturer: Beijing Choice Electronic Technology Co., Ltd.
Intended Use: The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.
3.4 Device Description
The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit.
The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness.
Its accessories include connecting wires, electrode pads, 2 AAA batteries.
The device is for over the counter use.
The device does not contain drug or biological products.
The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.
5
3.5 Comparison list of the technological characteristics
| Comparison Elements | Proposed Device | Predicate Device | Remark | |||
|---|---|---|---|---|---|---|
| 510(k) number | NA | K160508 | ||||
| Device Name/Model | Electronic Pulse Stimulator MDTS100 | Electronic | ||||
| Pulse | ||||||
| Stimulator | ||||||
| MDTS100 | ||||||
| Manufacturer | Beijing Choice Electronic Technology Co., Ltd. | Beijing | ||||
| Choice | ||||||
| Electronic | ||||||
| Technology Co., Ltd. | Same | |||||
| -Method | ||||||
| Isolation | of | |||||
| Line | Current | N/A for DC current | N/A for DC current | Same | ||
| Power | -Patient | -Normal condition |