(249 days)
Not Found
No
The device description details manual operation through buttons and a display, and there is no mention of AI, ML, or any adaptive or learning capabilities. The performance studies focus on electrical safety and software verification according to standard guidance, not AI/ML performance metrics.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) intended for temporary relief of pain and to stimulate muscles, which are therapeutic uses.
No.
The device description and intended use clearly state that it is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) used for temporary pain relief and muscle stimulation, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components such as electrodes, lead wires, an AC adapter, a USB cable, a main unit with a display screen, buttons, and a built-in battery, in addition to the software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a TENS and PMS unit that delivers electrical pulses to the skin for pain relief and muscle stimulation. It does not involve the analysis of any biological specimens.
- Intended Use: The intended use is for temporary pain relief and muscle stimulation, not for diagnosing or monitoring a medical condition through the analysis of in vitro samples.
The device is an external electrical stimulator, not an IVD.
N/A
Intended Use / Indications for Use
TENS (Transcutaneous Electric Nerve Stimulation): 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 work activities. Mode 1,3,4,5,6
PMS (Powered Muscle Stimulation): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Mode 2,6
Product codes
NUH, NGX
Device Description
The subject device MSLS6QF is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas.
This double-channel subject device, which is compact, portable, effectively transfer programmed electrical pulses directly through the self-adhesive electrodes to the suggested area of the body where the electrodes are placed. It delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation.
The subject device has 6 operation modes which can give certain electrical pulse through the 4 pcs of electrodes placed on the skin to help users to enjoy body stimulation. The subject device has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode, output intensity of the pulse, and time remaining of an application mode. The subject device could be easily operated through its toggle switch or buttons to manually realize its functions according to the need of users.
The subject device is equipped with accessories of the electrodes, lead wires, AC adapter and USB cable. The lead wire is used to connect the electrodes to the main unit; the USB cable is used to connect the AC adapter to the main unit when charging the built-in Li battery; the pads holders are used to storage the electrodes after therapy treatment for the convenience.
The self-adhesive electrodes are important accessories of the subject device, and are contact with the skin surface. It is consists of gel, carbon film, cloth backing ,and electrode connector. The electrode is complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, waist, back, upper extremities (arm), and lower extremities (leg)
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
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary standards in connection with medical device electrical safety, and electromagnetic compatibility.
(a) IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
(b) IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
(c) IEC 60601-2-10:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
(d) ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
(e) ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
(f) IEC 62133:2012 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
In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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.
September 4, 2020
Self Doctor Care, LLC Wei Wei Manager 8811 Teel Pkwy Ste 100, Unit 6141 Frisco, Texas 75036
Re: K193655
Trade/Device Name: MSLS6QF TENS/PMS Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: April 24, 2020 Received: June 9, 2020
Dear Wei Wei:
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,
Amber Ballard, PhD Acting 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) K193655
Device Name MSLS6QF TENS/PMS Device
Indications for Use (Describe)
TENS (Transcutaneous Electric Nerve Stimulation):
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 work activities. Mode 1,3,4,5,6
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. Mode 2,6
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
This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter's Information
Submitter: Self Doctor Care, LLC Address: 8811 Teel Pkwy Ste 100.Unit 6141, Frisco. TX 75036 Contact Person: Wei Wei Tel: 516-289-8425 Email: massagelossage@gmail.com Date of Preparation: 12/26/2019
2. Correspondent's Information
Correspondent: Self Doctor Care, LLC Address: 8811 Teel Pkwy Ste 100, Unit 6141, Frisco, TX 75036 Contact Person: Wei Wei Tel: 516-289-8425 Email: massagelossage@gmail.com
3. Subject Device
Device Name: MSLS6QF TENS/PMS Device Common Name: Transcutaneous electrical nerve stimulator (TENS) and Powered MuscleStimulator(PMS) Model: MSLS6QF Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter
4. Predicate device
Predicate Device: TENS&PMS, IQ Technologies
4
510(k) Number: K131290 Use: Over-The-Counter Submitter: IQ Technologies Inc.
5. Description of Subject Device
The subject device MSLS60F is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas.
This double-channel subject device, which is compact, portable, effectively transfer programmed electrical pulses directly through the self-adhesive electrodes to the suggested area of the body where the electrodes are placed. It delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation.
The subject device has 6 operation modes which can give certain electrical pulse through the 4 pcs of electrodes placed on the skin to help users to enjoy body stimulation. The subject device has the operating elements of ON/OFF Switch, Display screen, Mode Selection key and Intensity Modification keys. The LCD display screen can show selected mode, output intensity of the pulse, and time remaining of an application mode. The subject device could be easily operated through its toggle switch or buttons to manually realize its functions according to the need of users.
The subject device is equipped with accessories of the electrodes, lead wires, AC adapter and USB cable. The lead wire is used to connect the electrodes to the main unit; the USB cable is used to connect the AC adapter to the main unit when charging the built-in Li battery; the pads holders are used to storage the electrodes after therapy treatment for the convenience.
The self-adhesive electrodes are important accessories of the subject device, and are contact with the skin surface. It is consists of gel, carbon film, cloth backing ,and electrode connector. The electrode is complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
6. Intended Use of Subject Device
TENS (Transcutaneous Electric Nerve Stimulation):
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 work activities. Mode 1,3,4,5,6
PMS(Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate
5
muscle performance. Mode 2,6
7. Summary of Substantial Equivalence
The following table summarizes the comparison between the subject device and predicate devices, indicating the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.
Subject Device | Predicate Device | Judgment | ||
---|---|---|---|---|
510(k) Number | K193655 | K131290 | / | |
Company Name | Self Doctor Care, LLC | IQ Technologies Inc. | / | |
Device Name | MSLS6QF | IQ Technologies | / | |
Operational Principle | Generate small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves and/or muscles are activated | Generate small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves and/or muscles are activated | SE | |
Intended Use | TENS (Transcutaneous Electric Nerve Stimulation): | |||
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 work activities. | ||||
Mode 1,3,4,5,6 |
PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | 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 work activities.
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. | SE | |
| | | Mode 2,6 | | |
| Prescription/over-the-counter use | | OTC | OTC | SE |
| Power Source | | DC 3.7V Lithium Battery | DC 3.7V Lithium Battery | SE |
| Method of Line Current Isolation | | Type BF Applied Part | Type BF Applied Part | SE |
| Patient Leakage Current | | | | |
| - Normal Condition (μΑ) | | | | |
| - Single Fault Condition (μΑ) | |