MSLS6QF TENS/PMS Device

K193655 · Self Doctor Care, LLC · NUH · Sep 4, 2020 · Neurology

Device Facts

• Record ID: K193655
• Device Name: MSLS6QF TENS/PMS Device
• Applicant: Self Doctor Care, LLC
• Product Code: NUH · Neurology
• Decision Date: Sep 4, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

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. Mode 2,6

Device Story

Compact, portable, dual-channel TENS/PMS device; delivers programmed electrical pulses via self-adhesive electrodes to skin. User-operated via buttons/toggle switch; LCD displays mode, intensity, and time. Powered by internal rechargeable Li-battery (DC 3.7V). Includes 6 operation modes for pain relief and muscle stimulation. Used by patients in home/OTC settings. Output intensity and duration are manually controlled. Benefits include temporary pain relief and muscle conditioning.

Clinical Evidence

Bench testing only. Device validated for electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and nerve/muscle stimulator performance (IEC 60601-2-10). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Battery safety verified per IEC 62133.

Technological Characteristics

Dual-channel electrical stimulator; ABS housing; self-adhesive electrodes (gel, carbon film, cloth backing). Output: pulsed, rectangular waveform. Power: DC 3.7V Li-battery. Connectivity: USB for charging. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5/10, IEC 62133. Sterilization: Not specified.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, upper, and lower extremities due to exercise or household strain (TENS); and stimulation of healthy muscles to improve/facilitate performance (PMS). For OTC use.

Regulatory Classification

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.

Predicate Devices

• TENS&PMS, IQ Technologies (K131290)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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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# 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: [phone] Email: [e-mail] 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: [phone] Email: [e-mail]

## 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

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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

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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):<br>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.<br>Mode 1,3,4,5,6<br><br>PMS (Powered Muscle Stimulation):<br>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.<br><br>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) | | < 1 μΑ | | |
| | | 6 μΑ | Not publicly available | Note 1 |
| Number of output modes | | 6 | 6 | SE |
| Regulated Current or Regulated Voltage | | Voltage Control | Voltage Control | SE |
| Number of Output Channels | | 2 | 2 | SE |
| Automatic Overload Trip | | No | No | SE |
| Automatic No-Load Trip | | No | No | SE |
| Automatic Shut Off | | Yes | Yes | SE |
| User Override Control | | Yes | Yes | SE |
| | On/Off Status? | Yes | Yes | SE |
| | Low Battery? | Yes | Yes | SE |
| | Voltage/Current | | | |
| Indicator Display | Level? | No | No | SE |
| | | 10 ~ 60 minutes, | 10 ~ 60 minutes, | |
| Timer Range (minutes) | | 10 min/step | 10 min/step | SE |
| Weight(g) | | 40g | 37g | |
| Size(mm) | | 80×41×16 | 80×42×13 | Similar, |
| Housing Materials and Construction | | ABS | ABS and Aluminum alloy | Note 2 |
| Burst Mode | | | | |
| a) Pulses per burst | | | | |
| b) Bursts per second | | | | |
| c) Burst duration | | | | |
| (seconds) | | | | |
| d) Duty Cycle | | | | |
| [Line(b) x Line (c)] | | N/A (no pulse train or burst) | N/A | |
| ON Time (seconds) | | N/A | N/A | |
| OFF Time (seconds) | | N/A | N/A | |
| | | Self-adhesive Electrodes, | Self-adhesive Electrodes, | |
| | | Lead wires, | Lead wires, | |
| Accessories intended for use with device | | Battery charger, USB cable | Battery charger, USB | SE |
| | | cable | | |
| | Waveform | Pulsed | Pulsed | SE |
| | Shape | Rectangular | Rectangular | SE |
| | Maximum output voltage<br>(Volts +/- 20%) at 500Ω | Mode 1: 45.9<br>Mode 2: 61.6<br>Mode 3: 46.7<br>Mode 4: 39.0<br>Mode 5: 36.1<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 42<br>Mode 2: 63.2<br>Mode 3: 64<br>Mode 4: 34.4<br>Mode 5: 32<br>Mode 6: This mode<br>cycles the above five<br>modes | |
| | Maximum output voltage<br>(Volts +/- 20%) at 2kΩ | Mode 1: 74.2<br>Mode 2: 87.4<br>Mode 3: 60.5<br>Mode 4: 65.1<br>Mode 5: 60.5<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 80.8<br>Mode 2: 94.4<br>Mode 3: 87.2<br>Mode 4: 68<br>Mode 5: 64<br>Mode 6: This mode<br>cycles the above five<br>modes | Similar,<br>Note 3 |
| | Maximum output voltage<br>(Volts +/- 20%) at 10kΩ | Mode 1: 126.0<br>Mode 2: 128.0<br>Mode 3: 88.0<br>Mode 4: 124.7<br>Mode 5: 120.7<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 129<br>Mode 2: 129<br>Mode 3: 96.8<br>Mode 4: 128<br>Mode 5: 119<br>Mode 6: This mode<br>cycles the above five<br>modes | |
| | Maximum output current<br>(mA +/- 20%) at 500Ω | Mode 1: 91.8<br>Mode 2: 123.2<br>Mode 3: 93.4<br>Mode 4: 78.0<br>Mode 5: 72.2<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 84<br>Mode 2: 126.4<br>Mode 3: 128<br>Mode 4: 68.8<br>Mode 5: 64<br>Mode 6: This mode<br>cycles the above five<br>modes | |
| | | | | |
| Maximum output current<br>(mA +/- 20%) at 2KΩ | Mode 1: 37.1<br>Mode 2: 43.7<br>Mode 3: 30.3<br>Mode 4: 32.6<br>Mode 5: 30.3<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 40.4<br>Mode 2: 47.2<br>Mode 3: 43.6<br>Mode 4: 34<br>Mode 5: 32<br>Mode 6: This mode<br>cycles the above five<br>modes | | |
| Maximum output current<br>(mA +/- 20%) at 10KΩ | Mode 1: 12.6<br>Mode 2: 12.8<br>Mode 3: 8.8<br>Mode 4: 12.5<br>Mode 5: 12.1<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 12.9<br>Mode 2: 12.9<br>Mode 3: 9.7<br>Mode 4: 12.8<br>Mode 5: 11.9<br>Mode 6: This mode<br>cycles the above five<br>modes | | |
| Frequency (Hz) | Mode 1: 68.7<br>Mode 2: 12.2~53.4<br>Mode 3: 1.2<br>Mode 4: 96.1<br>Mode 5: 96.1<br>Mode 6: This mode<br>cycles the above five<br>modes | Mode 1: 69.4<br>Mode 2: 12.3~54.3<br>Mode 3: 1.2<br>Mode 4: 100<br>Mode 5: 100<br>Mode 6: This mode<br>cycles the above five<br>modes | | |
| | Mode 1: 14.6<br>Mode 2: 18.7~82.0<br>Mode 3: 840.0<br>Mode 4: 10.4<br>Mode 5: 10.4<br>Mode 6: This mode<br>cycles the above five<br>modes | | | |
| Pulse period (mSec) | | 10~840 | SE | |
| Pulse Width (µSec) | | 100 | SE | |
| Maximum Phase charge<br>(µC) at 500Ω | 17.42 | 16.8 | Similar, | |
| | Mode 1: 3.67 | Mode 1: 3.36 | Note 4 | |
| | Mode 2: 4.93 | Mode 2: 5.06 | | |
| | Mode 3: 3.74 | Mode 3: 5.12 | | |
| | Mode 4: 3.12 | Mode 4: 2.75 | | |
| | Mode 5: 2.89 | Mode 5: 2.56 | | |
| | Mode 6: This mode<br>cycles the above five<br>modes | Mode 6: This mode<br>cycles the above five<br>modes | | |
| Maximum current density<br>(mA/cm²) at 500Ω | | | | |
| | | | | |
| | Mode 1: 0.03556 | | | |
| | Mode 2: 0.0085~0.03726 | Not publicly available | | |
| | Mode 3: 0.00063 |…