TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Device Description

The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the TENS & EMS Device (Model: FM-B2403A):

Please note: This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, not a typical clinical trial report for an AI-powered diagnostic/treatment device. Therefore, many of the typical questions regarding AI device performance studies (like test set provenance, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or explicitly stated in this type of submission. The "acceptance criteria" here refer to regulatory standards and comparative technical specifications, not predictive performance metrics.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard	Predicate Device Performance (FM-B2403)	Proposed Device Performance (FM-B2403A)	Meets Criteria?
Regulatory Information	Regulation Numbers: 882.5890, 890.5850	882.5890, 890.5850	882.5890, 890.5850	Yes (SE)
	Classification: Class II	Class II	Class II	Yes (SE)
	Product Code: NUH, NGX	NUH, NGX	NUH, NGX	Yes (SE)
	Panel: Physical Medicine; Neurology	Physical Medicine; Neurology	Physical Medicine; Neurology	Yes (SE)
	OTC/RX: OTC	OTC	OTC	Yes (SE)
Intended Use	TENS: Temporary relief of pain associated with sore and aching muscles (specified body parts)	Same	Same	Yes (SE)
	EMS: Stimulate healthy muscles to improve/facilitate muscle performance	Same	Same	Yes (SE)
Physical Characteristics & Safety	Apply parts of the body	Shoulder, waist, back, neck, upper/lower extremities, abdomen, bottom	Shoulder, waist, back, neck, upper/lower extremities, abdomen, bottom	Yes (SE)
	Power Source	Built-in 3.7V lithium battery	Built-in 3.7V lithium battery	Yes (SE)
	Method of Line Current Isolation	BF	BF	Yes (SE)
	Patient Leakage Current - Normal Condition	<10µA	<10µA	Yes (SE)
	Patient Leakage Current - Single Fault Condition	<50µA	<50µA	Yes (SE)
	Number of Output Channels	4	4	Yes (SE)
	Synchronous or Alternating	Synchronous	Synchronous	Yes (SE)
	Method of Channel Isolation	By electrical circuit and software	By electrical circuit and software	Yes (SE)
	Regulated Current or Regulated Voltage	Regulated voltage control	Regulated voltage control	Yes (SE)
	Software/Firmware/Microprocessor Control?	Software	Software	Yes (SE)
	Automatic Overload Trip?	No	No	Yes (SE)
	Automatic No-Load Trip?	No	No	Yes (SE)
	Automatic Shut Off?	Yes	Yes	Yes (SE)
	Patient Override Control?	Yes	Yes	Yes (SE)
	Indicator Display: On/Off Status?	Yes	Yes	Yes (SE)
	Indicator Display: Low Battery?	Yes	Yes	Yes (SE)
	Indicator Display: Voltage/Current Level?	Yes	Yes	Yes (SE)
	Timer Range (minutes)	10~80	10~80	Yes (SE)
	Housing Materials and Construction	ABS	ABS	Yes (SE)
	Biocompatibility	All user directly contacting materials compliant with ISO10993-5 and ISO10993-10 requirements	All user directly contacting materials compliant with ISO10993-5 and ISO10993-10 requirements	Yes (SE)
	Compliance with Voluntary Standards	ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10	Same	Yes (SE)
	Compliance with 21 CFR 898?	Yes	Yes	Yes (SE)
Output Parameters	Waveform	Biphasic	Biphasic	Yes (SE)
	Shape	Rectangular	Rectangular	Yes (SE)
	Maximum Output Voltage (+/- 10%)	97.6@500Ω, 135@2KΩ, 157@10KΩ	98@500Ω, 150@2KΩ, 165@10KΩ	Yes (SE, Note 1)
	Maximum Output Current (+/- 10%)	195.2@500Ω, 67.5@2KΩ, 15.7@10KΩ	196@500Ω, 75@2KΩ, 16.5@10KΩ	Yes (SE, Note 1)
	Pulse Duration (µs)	90	50-180	Yes (SE, Note 1)
	Frequency† (Hz) [or Rate† (pps)]	<90.9	<199	Yes (SE, Note 1)
	Net Charge (µC per pulse)	0.001@500Ω	0.001@500Ω	Yes (SE)
	Maximum Phase Charge (µC)	15.5@500Ω	35@500Ω	Yes (SE, Note 2)
	Maximum Current Density (mA/cm2)	0.1192@500Ω	0.5645@500Ω	Yes (SE, Note 2)
	Maximum Power Density (mW/cm2)	0.176@500Ω	0.003984@500Ω	Yes (SE, Note 2)
	Pulses per burst	2	2	Yes (SE)
	Bursts per second	1/30	1/50	Yes (SE, Note 2)
	Burst duration (ms)	45	50	Yes (SE, Note 2)
	Duty Cycle: Line (b) x Line (%)	1.6%	7.2%	Yes (SE, Note 2)
	ON Time (seconds)	1	1	Yes (SE)
	OFF Time (seconds)	1	1	Yes (SE)
Accessories	Self-adhesive electrodes, electrode wires, adapter, USB cable	Same	Same	Yes (SE)
Physical (Minor differences claimed as insignificant)	Weight (g)	82g	86g	Yes (SE, Note 1 on Table 1)
	Dimensions (mm) [D x W x H]	1106015	1106124	Yes (SE, Note 1 on Table 1)
	Number of Output Modes	TENS:19, EMS:5	TENS:12, EMS:12	Yes (SE)

Note 1 (on Table 1): The weight, dimensions, and appearance of the proposed device FM-B2403A have small differences from the predicate device K202866, but these differences are insignificant and won't raise any new risk of safety and effectiveness.
Note 1 (on Table 3): Differences in maximum output voltage, maximum output current, pulse duration, and frequency have passed IEC 60601-2-10 test codes and won't raise new risks.
Note 2 (on Table 3): Differences in net charge, maximum phase charge, maximum current density, maximum power density, bursts per second, burst duration, and duty cycle do not exceed safety limits and have passed IEC 60601-2-10 tests. Maximum average power density <0.25Watts/cm². Therefore, these differences won't raise any new safety and effectiveness risk.

Study Information (Based on a 510(k) Submission for a TENS/EMS Device):

Sample size used for the test set and the data provenance:
- Test set size: Not applicable. This submission relies on non-clinical (bench) testing against recognized standards and technical comparisons to a predicate device, not clinical data from human subjects for performance evaluation.
- Data provenance: The performance data comes from non-clinical laboratory studies and safety testing, performed in a controlled environment as part of the device manufacturing and regulatory compliance process. The country of origin for the tests conducted is not explicitly stated but would typically be part of the manufacturer's internal quality management system and testing facilities (Shenzhen, China, in this case). The data is by nature prospective with respect to the regulatory submission, meaning the tests were conducted specifically to support this application.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. "Ground truth" in the AI/diagnostic sense is not relevant here. The "ground truth" for this device's performance is established by meeting electrical safety standards (e.g., IEC 60601 series) and comparing technical specifications to a previously cleared device. The compliance is assessed by engineers and technicians trained in these standards.
Adjudication method for the test set:
- Not applicable. There's no human interpretation or adjudication of outputs in the way you might find in an imaging AI study. The "adjudication" is through physical and electrical measurements and subsequent comparison to predefined pass/fail criteria from international safety standards and the predicate device's specifications.
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 direct-to-consumer TENS & EMS device, not an AI-assisted diagnostic or therapeutic tool with a human-in-the-loop component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. Similar to point 4, this is not an AI algorithm. The device's performance is evaluated based on its physical, electrical, and functional characteristics as a medical device.
The type of ground truth used:
- The "ground truth" for this submission are the international electrical safety and performance standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and the technical specifications of a legally marketed predicate device (K202866). The device is deemed safe and effective if it meets these established standards and is substantially equivalent in technology and intended use.
The sample size for the training set:
- Not applicable. This is not an AI or machine learning device requiring a training set.
How the ground truth for the training set was established:
- Not applicable. There is no training set.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 8, 2022

Shenzhen Jianfeng Electronic Technology Co. Ltd. Feng Wen General Manager 902, 903 Jialingyu Industrial Building, Da Pu Road Houting Village, Shajing Town, Baoan District Shenzhen, Guangdong 518104 China

Re: K213741

Trade/Device Name: TENS & EMS Device (Model: FM-B2403A) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH. NGX Dated: December 17, 2021 Received: December 17, 2021

Dear Feng Wen:

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

{1}------------------------------------------------

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 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 (QS) 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 medical devices and radiation-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,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213741

Device Name TENS & EMS Device (Model: FM-B2403A)

Indications for Use (Describe) TENS:

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

EMS:

The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary K213741

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Type of 510(k) submission: Traditional Date of the summary prepared: Feb-17-2022
1. Submitter's Information Submitter: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, 518104, China. Contact Person: Feng Wen Email: wenfeng@fzjhealth.com Tel: +86-755-33858361 Fax: +86-755-33858360

Application Correspondent Company: SHENZHEN JIAN FENG ELECTRONIC TECHNOLOGY CO., LTD. Address: 902, 903 Jialingyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, 518104, China. Contact Person: Feng Wen Title: General Manager Email: wenfeng@fzjhealth.com Tel: +86-755-33858361 Fax: +86-755-33858360

1. Subject Device Information
  Trade Name: TENS & EMS Device (Model: FM-B2403A) Common Name: TENS, EMS, Stimulator for pain relief; Classification Name: Powered muscle stimulator; Transcutaneous electrical nerve stimulator for pain relief; Nerve muscle stimulator Review Panel: Physical Medicine; Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890, 21 CFR 890.5850 Device Classification: Class II
Use: Over-the-Counter Use (OTC)
1. The Predicate Device Information

Basic Information	Predicate Device
Manufacturer	Shenzhen Jian Feng Electronic Technology Co., Ltd.

{4}------------------------------------------------

Device Name	TENS & EMS Device
Model	FM-B2403
510(K) Number	K202866
Product Code	NUH, NGX
Panel Code	Physical Medicine, Neurology
Regulation Number	21 CFR 882.5890
	21 CFR 890.5850
Regulation Class	Class II

5. Device Description / Design of Device

4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.

The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use.

Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.

6. Indication for Use

TENS:

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

EMS:

The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Technological characteristics and substantial equivalence

7.1 The following table is the basic characteristic:

{5}------------------------------------------------

Contents	New device	Predicate Device	SE
Trade Name	TENS & EMS Device	TENS & EMS Device	SE
Device Model	FM-B2403A	FM-B2403	/
510(k) Number	To Be Assigned	K202866	/
Manufacturer	Shenzhen Jian Feng ElectronicTechnology Co., Ltd.	Shenzhen Jian Feng ElectronicTechnology Co., Ltd.	SE
Regulatory Information	882.5890, 890.5850	882.5890, 890.5850	SE
Classification	Class II	Class II	SE
Product code	NUH, NGX	NUH, NGX	SE
Panel	Physical Medicine; Neurology	Physical Medicine; Neurology	SE
OTC/RX	OTC	OTC	SE
Intended Use	TENS: The device is designedto be used for temporary reliefof pain associated with soreand aching muscles in theshoulder, waist, back, neck,upper extremities (arm), lowerextremities (leg), abdomen andbottom due to strain fromexercise or normal householdwork activities.EMS: The device is designedto be used to stimulate healthymuscles in order to improve orfacilitate muscle performance.	TENS: The device is designedto be used for temporary reliefof pain associated with soreand aching muscles in theshoulder, waist, back, neck,upper extremities (arm), lowerextremities (leg), abdomen andbottom due to strain fromexercise or normal householdwork activities.EMS: The device is designedto be used to stimulate healthymuscles in order to improve orfacilitate muscle performance.	SE
Apply parts of the body	Shoulder, waist, back, neck,upper extremities (arm), lowerextremities (leg), abdomen andbottom	Shoulder, waist, back, neck,upper extremities (arm), lowerextremities (leg), abdomen andbottom	SE
Power Source	Built-in 3.7V lithium battery	Built-in 3.7V lithium battery	SE
- Method of Line CurrentIsolation	BF	BF	SE
- Patient Leakage Current	/	/	SE
- Normal condition	<10μΑ	<10μΑ	SE
- Single fault condition	<50μΑ	<50μΑ	SE
Number of Output Modes	TENS:12, EMS:12	TENS:19, EMS:5	SE
Number of OutputChannels	4	4	SE
Synchronous oralternating	Synchronous	Synchronous	SE
Method of ChannelIsolation	By electrical circuit andsoftware	By electrical circuit andsoftware	SE
Regulated Current orRegulated Voltage	Regulated voltage control	Regulated voltage control	SE
Software/Firmware/Microprocessor Control?	Software	Software	SE

Automatic Overload Trip?		No	No	SE
Automatic No-Load Trip?		No	No	SE
Automatic Shut Off?		Yes	Yes	SE
Patient Override Control?		Yes	Yes	SE
IndicatorDisplay	On/Off Status?	Yes	Yes	SE
	Low Battery?	Yes	Yes	SE
	Voltage/CurrentLevel?	Yes	Yes	SE
Timer Range (minutes)		10~80	10~80	SE
Compliance withVoluntary Standards?		Yes.ANSI/AAMI/ES 60601-1IEC60601-1-2IEC 60601-2-10IEC60601-1-11ISO10993-5ISO10993-10	Yes.ANSI/AAMI/ES 60601-1IEC60601-1-2IEC 60601-2-10IEC60601-1-11ISO10993-5ISO10993-10	SE
Accessories		Self-adhesive electrodes,electrode wires, adapter, USBcable	Self-adhesive electrodes,electrode wires, adapter, USBcable	SE
Compliance* with 21 CFR898?		Yes	Yes	SE
Weight(g)		86g	82 g	SE
Dimensions (mm) [D x WH]		1106124	1106015	SE,Note 1
Housing Materials andConstruction		ABS	ABS	SE
Biocompatibility		All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements	All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements	SE

Table 1. FM-B2403A

{6}------------------------------------------------

Note 1:

The proposed device FM-B2403A has passed the IEC 60601-1 and AAMI / ANSI ES60601-1 test . The weight, dimensions, appearance of proposed device FM-B2403A has a little different from predicate device K202866, but these differences are insignificant and won't raise any new risk of safety and effectiveness..

7.2 The following table is the output parameters:

Table 3 FM-B2403A

Contents	Proposed Device	Predicate Device	SE
Device Name, Model	FM-B2403A	FM-B2403	/
Waveform (e.g., pulsed monophasic,biphasic)	biphasic	biphasic	SE
Shape (e.g., rectangular, spike,rectified sinusoidal)	rectangular	rectangular	SE

{7}------------------------------------------------

Maximum Output Voltage (volts) (+/-10%)	98@500Ω150@2KΩ165@10KΩ	97.6@500Ω135@2KΩ157@10KΩ	SENote 1
Maximum Output Current (mA) (+/-10%)	196@500Ω75@2KΩ16.5@10KΩ	195.2@500Ω67.5@2KΩ15.7@10KΩ	SENote 1
Pulse Duration (us)	50-180	90	SE,Note 1
Frequency† (Hz) [or Rate† (pps)]	<199	< 90.9	SENote 1
Net Charge (micro coulombs (µC)per pulse) (If zero, state method ofachieving zero net charge.)	0.001@500Ω	0.001@500Ω	SE
Maximum Phase Charge, (µC)	35@500Ω	15.5@500Ω	SENote 2
Maximum Current Density(mA/cm2)	0.5645@500Ω	0.1192@500Ω	SENote 2
Maximum Power Density(mW/cm2)	0.003984@500Ω	0.176@500Ω	SENote 2
Pulses per burst	2	2	SE
Bursts per second	1/50	1/30	SENote 2
Burst duration (ms)	50	45	SENote 2
Duty Cycle: Line (b) x Line (%)	7.2%	1.6%	SENote 2
ON Time (seconds)	1	1	SE
OFF Time (seconds)	1	1	SE

Comparison:

Note 1: There are some differences on the maximum output voltage .maximum Output current. pulse duration, frequency between proposed device and predicate device K202866.All these parameters have passed IEC 60601-2-10 test codes. Therefore, these differences won't raise any new risk of safety and effectiveness.

Note 2:There are some differences on the net charge, maximum current density ,maximum power density, bursts per second, burst duration and duty cycle between the proposed device and the predicate device K202866,but these parameters don't exceed the safety limit and have passed IEC 60601-2-10 test. The maximum average power density <0.25Watts/cm². Therefore, these differences won't raise any new safety and effectiveness risk.

Non-clinical studies and tests performance:

Non-clinical tests have been conducted to verify that the transcutaneous electrical nerve stimulator and/or powered muscle stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the targeted device complies with the following standards:

ANSI/AAMI/ES 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance

IEC60601-1-11, 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

IEC60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.

{8}------------------------------------------------

The body-contacting components of this device are electrode patches. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K092546, so we have reason to believe that the electrode patches are safe for the users. The electrode patches comply to the following standards:

ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity;
ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.

1. Clinical Performance Data Not applicable.
1. Final conclusion:

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the model FM-B2403A is substantially equivalent to the predicate device K202866.

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).