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.

Device Description

The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles. The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic. The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain. The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The MDTS100 comes with 2 independent output channels by pressing the CHA button. Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Electronic Pulse Stimulator Model MDTS100, which is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device (Prospera OTC TENSE Electronic Pulse Massager, Model PL029, K122744).

The document details the device's indications for use, its technical characteristics compared to the predicate, and functional and safety testing performed.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical effectiveness. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, which inherently means meeting safety and performance characteristics similar to a device already deemed safe and effective by the FDA. The comparison tables (Table 3-1 and Table 3-2) illustrate the technical characteristics of the proposed device against the predicate.

While no quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device, a table comparing key technical parameters and their reported values for both the proposed and predicate device is provided.

Table: Comparison of Technical Characteristics and Performance

Parameter	Proposed Device (MDTS100)	Predicate Device (PL029)	Implied "Acceptance Criteria" (Substantial Equivalence)
Power Source	DC 3V, 2 AAA batteries	3V Battery	Similar power source characteristics
Normal Condition Leakage Current	≤10 µA	2.0 µA	Acceptable leakage current (within safety standards)
Single Fault Condition Leakage Current	≤50 µA	3.0 µA	Acceptable leakage current (within safety standards)
Avg DC current (device on, no pulses)	≤10 µA	0 µA	Acceptable DC current (within safety standards)
Number of Output Modes	7	8	Similar range of therapy modes
Output Type	Alternating	Alternating	Similar output channel handling
Regulated Output	Regulated Voltage	Voltage control	Similar output regulation type
Software/Firmware Control	Yes	Yes	Software-driven operation
Automatic Overload Trip?	No	No	Not present in either
Automatic No-Load Trip?	Yes	No	Enhanced safety feature in proposed
Automatic Shut Off?	Yes	Yes	Presence of critical safety feature
User Override Control?	Yes	Yes	User control over therapy
Display: On/OFF Status?	Yes	Yes	Basic operational display
Display: Low Battery?	Yes	No	Enhanced user information in proposed
Display: Voltage/Current Level?	Yes	No	Enhanced user information in proposed
Timer Range (minutes)	20 minutes	5, 10 minutes	Similar timer functionality
Compliance with Voluntary Standards?	Yes	Yes	Compliance with relevant safety standards
Compliance with 21 CFR 898?	Yes	Yes	Compliance with FDA regulations
Waveform	pulsed monophasic	Monophasic	Similar waveform characteristics
Shape	Rectangular	Rectangular	Similar waveform shape
Max Output Voltage (volts) (+/- 20%)	150V@500Ω, 160V@2kΩ, 165V@10kΩ	49.6V@500Ω, 99.2V@2kΩ, 114V@10kΩ	While different, the conclusion states they "do not raise any new questions of safety or effectiveness."
Maximum Output Current (mA) (+/- 20%)	18mA@500Ω, 3.2mA@2kΩ, 16.5mA@10kΩ	300mA@500Ω, 80mA@2kΩ, 0.6mA@10kΩ	While different, the conclusion states they "do not raise any new questions of safety or effectiveness."
Pulse Duration (µsec)	50~140 µsec	120~6800 µsec	While different, the conclusion states they "do not raise any new questions of safety or effectiveness."
Frequency (Hz)	0.9Hz~82Hz	0.5~86Hz	Similar frequency range
Net Charge (µC per pulse) @500Ω	42 µC	18000 µC	While different, the conclusion states they "do not raise any new questions of safety or effectiveness."
Max Phase Charge (µC) @500Ω	42 µC	23 µC	While different, the conclusion states they "do not raise any new questions of safety or effectiveness."
Max Current Density (mA/cm2, r.m.s.)	3.3mA/cm2@1.57"x1.57"Elec Pad	1.4mA/cm2	While different, the conclusion states they "do not raise any new questions of safety or effectiveness."
Burst Mode characteristics	E.g., Pulses/burst: 197, Burst/sec: 0.185	Some values like 1, 0-7	Different but concluded as not raising new safety/effectiveness questions.

The document concludes that the differences in output parameters (voltage, current, pulse duration, charge) between the proposed device and the predicate device "do not raise any new questions of safety or effectiveness." This statement effectively serves as the "acceptance criteria" for these differing parameters – that they fall within a range considered safe and effective for TENS devices when evaluated against recognized safety standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document focuses on non-clinical (bench) testing for substantial equivalence, not clinical studies involving human subjects with a "test set" in the context of clinical performance. Therefore, there is no mention of a human "test set" sample size or data provenance in this submission.

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

Not applicable. This is a non-clinical submission. Ground truth, in a clinical context, is not established for this type of submission.

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

Not applicable. This is a non-clinical submission.

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 an Electronic Pulse Stimulator (TENS), not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant to this submission.

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

Not applicable. While the device is "software-driven," the performance evaluation is not an "algorithm-only" standalone test in the context of AI or diagnostic algorithms. The device's performance is tested as a complete system (hardware and software) through bench testing against electrical safety and EMC standards.

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

For the non-clinical testing:

Electrical Safety & EMC: The "ground truth" is defined by the voluntary standards cited: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, and IEC 60601-2-10:2012. These standards specify thresholds and testing methodologies for electrical characteristics, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators.
Biocompatibility: The "ground truth" for the electrode pads is established by their prior FDA clearance (K090198) and compliance with ISO 10993 standards, which cover biological evaluation of medical devices.
Software Validation: The "ground truth" for software functionality is established against the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
Cleaning: The "ground truth" is simply that the cleaning instructions were tested and found sufficient, as presented in the system test report.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set."

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

Not applicable. This is not an AI/machine learning device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 21, 2016

Beijing Choice Electronic Technololgy Co., Ltd. Lei Chen Quality Director No.9 Shuangyuan Road, Badach Hi-tech Zone Shijingshan District Beijing, 100041 CN

Re: K160508

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: February 22, 2016 Received: February 24, 2016

Dear Lei Chen:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

William J.	Digitally signed by William J. H
Heetderks -A

DN:	c=US, o=U.S. Government
ou=	People,
	0.9.2342.19200300.100.1.1=00
cn=	William J. Heetderks -A
Date:	2016.11.21 21:22:10 -05"

for	Carlos L. Peña, PhD, MS
	Director
	Division of Neurological
	and Physical Medicine Devices
	Office of Device Evaluation
	Center for Devices and Radiological Health

Enclosure

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Section II Indications for Use Statement

Indications for Use

510(k) Number (if known): Device Name: Electronic Pulse Stimulator Model:

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use	V
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92.

3.1 Submitter Information

Manufacturer Name:

Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104,No.A12 Yuquan Road Haidian District 100143 Beijing, P.R.China

Contact Person:

Mr.Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com Date prepared: October 31, 2016

3.2 Proposed Device Information

Device Common Name: Transcutaneous Electrical Nerve Stimulator, OTC

Device Trade/Proprietary Name: Electronic Pulse Stimulator

Model: MDTS100

Classification Name: Transcutaneous Electrical Nerve Stimulator for pain relief

Regulation Number: 21 CFR 882.5890

Product Code: NUH

Class: II

Use: Over -The-Counter Use

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Panel: Neurology

3.3 Predicate Device

510(k) Number: K122744

Common Name: Transcutaneous electrical nerve stimulator OTC

Device Trade/Proprietary Name: Prospera OTC TENSE Electronic Pulse Massager

Model: PL029

Classification Name: Transcutaneous Electrical Nerve Stimulator for pain relief

Product Code: NUH, NGX

Regulation Number: 21 CFR 882.5890

Device Class: II

Panel: Neurology

Use: Over-The-Counter Use

Manufacturer: Prospera Corporation

Intended Use:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm), and lower extremities(leg) due to strain from exercise or normal household work activities.

3.4 Device Description

The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic.

The MDTS100 is adopted the method that inputting the specific low frequency pulse

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Premarket Notification 510(k) Submission-510(k) Summary

current into the human body through the human skin to treat the pain.

The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit.

The MDTS100 comes with 2 independent output channels by pressing the CHA button.

Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes.

The proposed device is not for life-supporting or life-sustaining, not for implant.

The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization.

The device is for over the counter use.

The device does not contain drug or biological products.

The device is software-driven and software validation is provided in software.

3.5 Indication for Use

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3.6 Comparison list of technical characteristics

Parameter	Proposed Device	Predicate Device
510(k) number	(to be assigned)	K122744
Device Name and Model	MDTS100	PL029
Manufacturer	Beijing Choice Electronic Technology Co., Ltd.	Prospera
Power Source	DC 3V, 2 AAA batteries	3V Battery
-Method of Line Current Isolation	N/A for DC current	Battery Supply N/A
-patient Leakage Current	--	--
-Normal Condition( $\mu$ A)	≤10 $\mu$ A	2.0 $\mu$ A
-Single Fault Condition( $\mu$ A)	≤50 $\mu$ A	3.0 $\mu$ A
Average DC current through electrodes when device is on but no pulses are being applied( $\mu$ A)	≤10 $\mu$ A	0 $\mu$ A
Number of Output Modes	7	8
Number of Synchronous or Output Alternating?	Alternating	Alternating
Channels Method of Channel Isolation	No	By software
Regulated Current or Regulated Voltage?	Regulated Voltage	Voltage control
Software/Firmware/Microprocessor Control?	Yes	Yes

Table 3-1 Basic Unit Characteristics Comparison Table between the Proposed Device (MDTS100) and Predicate Device

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Premarket Notification 510(k) Submission—510(k) Summary

Maximum Output Current (specify units) (+/- 20

Automatic Overload Trip?	No	No
Automatic No-Load Trip?	Yes	No
Automatic Shut Off?	Yes	Yes
User Override Control?	Yes	Yes
Display:	On/OFF Status?	Yes	Yes
	Low Battery?	Yes	No
	Voltage/Current Level?	Yes	No
Timer Range (minutes)	20 minutes	5minutes, 10 minutes
Compliance with Voluntary Standards?	Yes	Yes
Compliance with 21 CFR 898?	Yes	Yes
Weight (lbs., oz.)	0 lb., 2.2 oz. ( Battery Excluded )	0 lb, 8.21oz.
Dimensions (in.) [W x H x D]	2.17x 5.12x0.87	2.24x7.87x0.83
Housing Materials and Construction	Enclosure: ABS	Enclosure: ABS
Table 3-2 Output Specification Comparison Table between the Proposed Device (MDTS100) and Predicate Device
Parameter	Proposed Device	Predicate Device
Device Name and Model	MDTS100	PL029
Waveform	pulsed monophasic	Monophasic
Shape	Rectangular	Rectangular
Maximum Output Voltage (volts) (+/- 20 %)	150V@500 Ω160V @2kΩ165V@10kΩ	49.6V@500 Ω99.2V@2kΩ114V @10k Ω

		16.5mA @10k Ω	0.6mA @10k Ω
Duration of primary (depolarizing) phase (µsec)		0µsec	40msec
Pulse Duration (µsec)		50~140µsec	120~6800µsec
Frequency (Hz) [or Rate (pps)]		0.9Hz~82Hz	0.5~86Hz
Net Charge (microcoulombs (µC) per pulse) @500Ω		42µC	18000µC
Maximum Phase Charge, (µC) @500Ω		42µC	23µC
Maximum Current Density, (mA/cm2, r.m.s.)		3.3mA/cm2@1.57"×1.57"ElectrodePad	1.4mA/cm2
Maximum Average Current (average absolute value), mA		2.8mA	---
Maximum Average Power Density, (W/cm2),(using smallest electrode conductive surface rate)		0.02W/cm2@1.57"×1.57"ElectrodePad	0.23 W/cm2
Burst Mode	(a) Pulses per burst	197	1
	(b) Burst per second	0.185	0-7
	(c) Burst duration (seconds)	2.4s	1
	(d) Duty Cycle: Line(b) x Line(c)	0.44	7
ON TIME (seconds)		<1second	40ms
OFF TIME (seconds)		<1second	18ms
Additional Features		---	---

18mA @500 Ω

3.2mA@2k Ω

300mA @500 Ω

80mA@2k Ω

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Premarket Notification 510(k) Submission—510(k) Summary

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Premarket Notification 510(k) Submission-510(k) Summary

Conclusion: The data in Table 3-1 and Table 3-2 indicates that the technical characteristics, features, specifications and intended use of the two devices are very similar. Both systems are designed to relief pain in the muscle areas. Outputs are almost the identical, each can produce square electronic pulses and positive-going waveform output. Both devices have selection modes to allow users to select preset programs and adjust intensity level by pressing the keypad on the main unit. Both devices are transiting pulses by the use of Electrode Pads. Technological characteristics, features, specifications, materials and intended uses of the new device are substantially equivalent to the quoted predicated device. The parameters such as waveform, frequency, pulse width, output current and voltage, although not exactly similar to this particular predicate, they do not raise any new questions of safety or effectiveness. The differences that exist between the devices are insignificant in terms of safety and effectiveness.

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3.7 Functional and Safety Testing:

Non-clinical tests were performed on the subject matter device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medial device electrical safety, electromagnetic compatibility, and particular requirements for the safety of nerve and muscle stimulator:

EMC and electrical Safety

IEC 60601-1:2005 Medical electrical equipment-Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2:2007 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic compatibility-Requirements and tests.

IEC 60601-1-11: 2010 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: 2012Medical electrical equipment-Part 2-10: Particular requirements for the safety of nerve and muscle stimulator.

Biocompatibility

The electrode pads are the mainly body contacting parts. Electrode pads, as accessories of the subject matter device, are adopted the Self-adhesive Electrode manufactured by Wuxi Jiajian Medical Instrument Co., Ltd. and have been cleared by FDA in June 23, 2009 as K090198. The patient contacting electrodes comply with ISO 10993 and are considered Class A ≤24 hours contact.

Software

In addition to the compliance of voluntary standards, the software verification has been carries out according to the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.

Cleaning

The cleaning instructions as described in the Instruction Manual have been tested to be sufficient. The test result was presented in the system test report in Performance Testing.

3.8 Conclusion

The Electronic Pulse Stimulator MDTS100 has the similar intended use and technological characteristics as the predicate device. Moreover, bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and

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Premarket Notification 510(k) Submission—510(k) Summary

effectiveness as that of the predicate device. In other words, the differences do not affect the intended use and do not raise any new questions of safety or effectiveness or alter the fundamental scientific technology of the device. Thus, the proposed device MDTS100 is substantially equivalent to the predicate device.

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).