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 Description

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).

AI/ML Overview

The document describes the acceptance criteria and study for the MSLS6QF TENS/PMS Device, establishing its substantial equivalence to a predicate device (IQ Technologies, K131290).

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this 510(k) submission are based on demonstrating "substantial equivalence" to a legally marketed predicate device (IQ Technologies, K131290). This is achieved by comparing technical characteristics, specifications, and intended use, and complying with relevant voluntary standards.

Acceptance Criteria Category	Specific Criteria/Comparison Point	Subject Device (MSLS6QF) Reported Performance	Predicate Device (IQ Technologies) Reported Performance	Judgment/Comment
Intended Use	TENS for pain relief	Temporary relief of pain in shoulder, waist, back, upper/lower extremities from strain. Modes 1,3,4,5,6.	Temporary relief of pain in shoulder, waist, back, upper/lower extremities from strain.	SE
	PMS for muscle performance	Stimulate healthy muscles to improve/facilitate muscle performance. Modes 2,6.	Stimulate healthy muscles to improve/facilitate muscle performance.	SE
Classification	Use Type	Over-The-Counter (OTC)	Over-The-Counter (OTC)	SE
Operational Principle	Mechanism of action	Generate small electrical pulses to activate nerves/muscles.	Generate small electrical pulses to activate nerves/muscles.	SE
Electrical Safety	IEC 60601-1 (General req. for basic safety & essential performance)	Compliance demonstrated through non-clinical testing.	Compliance demonstrated.	SE
	IEC 60601-1-2 (EMC Req. & Tests)	Compliance demonstrated through non-clinical testing.	Compliance demonstrated.	SE
	IEC 60601-2-10 (Nerve & Muscle Stimulators)	Compliance demonstrated through non-clinical testing.	Compliance demonstrated.	SE
	Patient Leakage Current	Passed (< 1 μΑ Normal, 6 μΑ Single Fault)	(< 1 μΑ Normal, 6 μΑ Single Fault)	SE (Note 1)
Biocompatibility	ISO 10993-5 (Cytotoxicity)	Electrodes complying.	Not explicitly stated for predicate in comparison table, but assumed compliance.	SE
	ISO 10993-10 (Irritation & Sensitization)	Electrodes complying.	Not explicitly stated for predicate in comparison table, but assumed compliance.	SE
Hardware/Software	Software Verification	Carried out per FDA Guidance.	Not explicitly detailed, assumed compliance.	SE
Physical Characteristics	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
	Number of output modes	6	6	SE
	Regulated Current/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
	Indicator Display	On/Off Status, Low Battery	On/Off Status, Low Battery	SE
	Timer Range (minutes)	10 ~ 60 minutes, 10 min/step	10 ~ 60 minutes, 10 min/step	SE
	Weight (g)	40g	37g	Similar (Note 2)
	Size (mm)	80×41×16	80×42×13	Similar (Note 2)
	Housing Materials & Construction	ABS	ABS and Aluminum alloy	Similar (Note 2)
	Waveform	Pulsed, Rectangular	Pulsed, Rectangular	SE
Output Parameters	Maximum output voltage (500Ω, 2kΩ, 10kΩ)	Values provided for each mode.	Values provided for each mode.	Similar (Note 3)
	Maximum output current (500Ω, 2kΩ, 10kΩ)	Values provided for each mode.	Values provided for each mode.	Similar (Note 3)
	Frequency (Hz)	Values provided for each mode. (e.g., Mode 1: 68.7, Mode 2: 12.2~53.4)	Values provided for each mode. (e.g., Mode 1: 69.4, Mode 2: 12.3~54.3)	Similar (Note 3)
	Pulse period (mSec)	Values provided for each mode. (e.g., Mode 1: 14.6, Mode 2: 18.7~82.0)	10~840	Similar (Note 3)
	Pulse Width (µSec)	100	100	SE
	Maximum Phase charge (µC) at 500Ω	17.42 µC total. Values for each mode. (e.g., Mode 1: 3.67; Predicate: 3.36)	16.8 µC total. Values for each mode.	Similar (Note 4)
	Maximum current density (mA/cm²) @ 500Ω, 2kΩ, 10kΩ	Values provided for each mode. (e.g., Mode 1: 0.03556 @ 500Ω)	Not publicly available for predicate in comparison table.	Note 5
	Maximum average current density (mA/cm²) @ 500Ω, 2kΩ, 10kΩ	Values provided for each mode. (e.g., Mode 1: 1.63 @ 500Ω)	Values provided for each mode (e.g., Mode 2: 0.85~3.75 @ 500Ω)	Note 5
	Maximum average power density (mW/cm²) @ 500Ω, 2kΩ, 10kΩ	Values provided for each mode. (e.g., Mode 1: 0.01437 @ 500Ω)	Mode 2: 0.85~3.75 @ 500Ω. Others not publicly available.	Note 5
Regulatory Compliance	21 CFR 898	Yes	Yes	SE

Notes from the document:

Note 1 (Patient Leakage Current): Predicate device info not publicly available, but subject device passed IEC 60601-1 tests.
Note 2 (Weight, Dimensions, Housing Materials): Differences are small and insignificant, not raising safety/effectiveness issues.
Note 3 (Output Voltage, Current, Pulse Width, Frequency): Differences are insignificant and do not raise new safety/effectiveness issues.
Note 4 (Maximum Phase Charge): Differences are insignificant and do not raise new safety/effectiveness issues, and the max value does not exceed safety limits.
Note 5 (Current Density, Average Power Density): Subject device values do not exceed safety limits and passed IEC 60601-2-10 tests. Predicate device public data for some parameters (e.g., max avg power density @ 500Ω) are similar and both are below 250mW/cm².

2. Sample size used for the test set and the data provenance:

The document describes non-clinical tests performed to validate the design and assure conformance with voluntary standards. It explicitly states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there is no patient test set as described in the question, but rather engineering and bench testing against recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Since no clinical test set was used, no experts were involved in establishing ground truth for patient data. The "ground truth" for the device's performance was established by compliance with the referenced voluntary standards (IEC, ISO).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a TENS/PMS device, not an AI-powered diagnostic imaging device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a standalone TENS/PMS device; the concept of "algorithm only" performance in the context of AI does not apply. Its performance is evaluated through compliance with electrical and biocompatibility standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the device's safety and effectiveness is established through adherence to voluntary industry standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and FDA guidance for software, demonstrating that its performance parameters fall within acceptable bounds and are substantially equivalent to a cleared predicate device.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning product and does not involve training sets.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set.

Summary

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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

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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 (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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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

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510(k) Number: K131290 Use: Over-The-Counter Submitter: IQ Technologies Inc.

5. Description of Subject Device

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):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 1,3,4,5,6PMS (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)		< 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(Volts +/- 20%) at 500Ω	Mode 1: 45.9Mode 2: 61.6Mode 3: 46.7Mode 4: 39.0Mode 5: 36.1Mode 6: This modecycles the above fivemodes	Mode 1: 42Mode 2: 63.2Mode 3: 64Mode 4: 34.4Mode 5: 32Mode 6: This modecycles the above fivemodes
	Maximum output voltage(Volts +/- 20%) at 2kΩ	Mode 1: 74.2Mode 2: 87.4Mode 3: 60.5Mode 4: 65.1Mode 5: 60.5Mode 6: This modecycles the above fivemodes	Mode 1: 80.8Mode 2: 94.4Mode 3: 87.2Mode 4: 68Mode 5: 64Mode 6: This modecycles the above fivemodes	Similar,Note 3
	Maximum output voltage(Volts +/- 20%) at 10kΩ	Mode 1: 126.0Mode 2: 128.0Mode 3: 88.0Mode 4: 124.7Mode 5: 120.7Mode 6: This modecycles the above fivemodes	Mode 1: 129Mode 2: 129Mode 3: 96.8Mode 4: 128Mode 5: 119Mode 6: This modecycles the above fivemodes
	Maximum output current(mA +/- 20%) at 500Ω	Mode 1: 91.8Mode 2: 123.2Mode 3: 93.4Mode 4: 78.0Mode 5: 72.2Mode 6: This modecycles the above fivemodes	Mode 1: 84Mode 2: 126.4Mode 3: 128Mode 4: 68.8Mode 5: 64Mode 6: This modecycles the above fivemodes

Maximum output current(mA +/- 20%) at 2KΩ	Mode 1: 37.1Mode 2: 43.7Mode 3: 30.3Mode 4: 32.6Mode 5: 30.3Mode 6: This modecycles the above fivemodes	Mode 1: 40.4Mode 2: 47.2Mode 3: 43.6Mode 4: 34Mode 5: 32Mode 6: This modecycles the above fivemodes
Maximum output current(mA +/- 20%) at 10KΩ	Mode 1: 12.6Mode 2: 12.8Mode 3: 8.8Mode 4: 12.5Mode 5: 12.1Mode 6: This modecycles the above fivemodes	Mode 1: 12.9Mode 2: 12.9Mode 3: 9.7Mode 4: 12.8Mode 5: 11.9Mode 6: This modecycles the above fivemodes
Frequency (Hz)	Mode 1: 68.7Mode 2: 12.2~53.4Mode 3: 1.2Mode 4: 96.1Mode 5: 96.1Mode 6: This modecycles the above fivemodes	Mode 1: 69.4Mode 2: 12.3~54.3Mode 3: 1.2Mode 4: 100Mode 5: 100Mode 6: This modecycles the above fivemodes
	Mode 1: 14.6Mode 2: 18.7~82.0Mode 3: 840.0Mode 4: 10.4Mode 5: 10.4Mode 6: This modecycles the above fivemodes
Pulse period (mSec)		10~840	SE
Pulse Width (µSec)		100	SE
Maximum Phase charge(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 modecycles the above fivemodes	Mode 6: This modecycles the above fivemodes
Maximum current density(mA/cm²) at 500Ω

	Mode 1: 0.03556
	Mode 2: 0.0085~0.03726	Not publicly available
	Mode 3: 0.00063
	Mode 4: 0.04242
	Mode 5: 0.03927
	Mode 6: This modecycles the above fivemodes
Maximum average current density@500Ω(mA/cm²)

	Mode 1: 1.63
	Mode 2: 0.52~2.30	Mode 2: 0.85~3.75
	Mode 3: 0.03	Mode 3: 0.08
	Mode 4: 1.65	Mode 4: 2.05
	Mode 5: 1.42	Mode 5: 1.64
	Mode 6: This modecycles the above fivemodes	Mode 6: This modecycles the above fivemodes
Maximum average powerdensity (mW/cm²) at 500Ω

	Mode 1: 0.01437	Not publicly available
	Mode 2: 0.0030~0.0132
	Mode 3: 0.00020
	Mode 4: 0.01770
	Mode 5: 0.01645
	Mode 6: This modecycles the above fivemodes
Maximum average current density@2ΚΩ(mA/cm²)

	Mode 1: 1.06643
	Mode 2: 0.2634~1.1552
	Mode 3: 0.01232
	Mode 4: 1.15241
	Mode 5: 0.99531
	Mode 6: This modecycles the above fivemodes
Maximum average powerdensity (mW/cm²) @2ΚΩ

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Maximum average current density@ $10KΩ$ (mA/cm²)	Mode 1: 0.00488Mode 2: 0.0009~0.0039Mode 3: 0.00006Mode 4: 0.00678Mode 5: 0.00656Mode 6: This modecycles the above fivemodes	Not publicly available
Maximum average powerdensity (mW/cm²) @ $10KΩ$	Mode 1: 0.61503Mode 2: 0.1130~0.4956Mode 3: 0.00521Mode 4: 0.84569Mode 5: 0.79230Mode 6: This modecycles the above fivemodes	Not publicly available
Compliance with VoluntaryStandards	IEC 60601-1, IEC60601-1-2, IEC 60601-2-10	IEC 60601-1, IEC60601-1-2, IEC 60601-2-10 SE
Compliance with 21 CFR898	Yes	Yes SE

Comparison in details:

Note 1: The Predicate Device K131290 this information is Not publicly available. The subject device MSLS6QF which conformance to the IEC 60601-1:2012 passed the Leakage Current tests already. So the Subject Device will not raise new problem of safety and effectiveness in this issue.

Note 2: The weight, dimensions differences between the subject device and the predicate device are very small. These differences won't raise any safety or effectiveness issue. And the housing material, appearance of subject device MSLS6QF are a little different from predicate device K131290. Consider the same intended use, components, working principle, test standards, these differences are insignificant in the terms of safety or effectiveness.

Note 3: There are some differences on the maximum output voltage, maximum output current, pulse width, frequency between the subject device and predicate device. But the differences are very insignificant. So these differences don't raise any new safety and effectiveness issues.

Note 4: Maximum current density(mA/cm2) @ 500Ω, differences between the subject device and predicate device are very insignificant. And this parameter max value does not exceed the safety limit. So it does not raise any new safety and effectiveness issues.

Note 5:Based on the calculation ,maximum average current density and maximum average power density, these parameters of the subject device MSLS6QF don't exceed the safety limit. And these parameters have passed IEC 60601-2-10 test codes. Although the predicate device K131290

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only public Maximum average power density (mW/cm2) at 500Ω, this is simulating worst case conditions and considering the load range the device is expected to encounter with normal use. The differences of Maximum average power density (mW/cm²) @500Ω for the subject device and predicate device are very insignificant. Both of the maximum average power density data for the subject device and predicate device are much lower than the 250mW/cm². So these differences don't raise any new safety and effectiveness issues.

Comparison Conclusion

Although the technological characteristics are a little different between the subject device and the predicate device, they all comply with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 requirement, FDA guidance requirement for Transcutaneous Electrical Nerve Stimulator for Pain Relief and FDA guidance requirement for Powered Muscle Stimulator for Muscle Conditioning.

So the differences of function specification will not raise any safety or effectiveness issue.

8.Substantial Equivalence

The operational principle of the predicate device IO Technologies is to 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. The subject device MSLS6QF indicates the same principle.

The comparison of the performance data and other aspects between the subject device and predicate device demonstrates the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate device.

The electrical stimulation provided by the MSLS6QF device is substantially equivalent to that commonly employed by muscle stimulator and TENS devices that have been cleared for marketing without prescription labeling:i.e. for OTC sale. The pulses in the wave form combinations are restricted in amplitude and duration to values consistent with the other device quote above.

The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

The MSLS60F device offers substantially equivalent technical specifications, features and effective results as the predicate device listed.

The technological characteristics, features, specifications, materials and intended uses of the MSLS6QF device are substantially equivalent to the quoted predicate device.

9.Non-Clinical Tests Performed

The subject device does not conduct, nor rely upon, clinical tests to determine substantial

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equivalence. 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.

10. Conclusion

The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the subject device MSLS6QF is substantially equivalent to the predicate device IQ Technologies. Therefore, the subject device is as safe and effective as the foregoing identified OTC predicate devices that have been legally marketed in the United States.

Regulation Number and Section

§ 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).