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 subject device (Model: FM-B2403) 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. 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.

AI/ML Overview

This document is a 510(k) Premarket Notification for a TENS & EMS Device (Model FM-B2403). It outlines the device's characteristics and demonstrates its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, Model SEM44).

It's important to note that this document does not describe a study involving an algorithm or AI. Instead, it focuses on the physical and electrical specifications of a medical device (a TENS and EMS stimulator) and compares them directly to a legally marketed predicate device to establish substantial equivalence for regulatory clearance. Therefore, many of the requested details about acceptance criteria for an AI/algorithm-based device and its study will not be present in this type of submission.

However, I can extract the information relevant to this specific device's acceptance strategy, which relies on demonstrating substantial equivalence to a predicate device through non-clinical testing of its physical and electrical parameters.

Here's a breakdown of the available information based on your request, adapted to the context of this traditional medical device submission:

1. A table of acceptance criteria and the reported device performance

For this type of device, the "acceptance criteria" are not framed as performance metrics against a clinical ground truth for an algorithm. Instead, they are the technical specifications and safety standards measured against the predicate device's characteristics and recognized industry standards. The "reported device performance" is essentially its measured engineering specifications.

The table in Section 7.1 and 7.2 of the 510(k) Summary serves this purpose. The "SE" column indicates "Substantially Equivalent," implying that the subject device's performance (its measured characteristics) meets the criteria for substantial equivalence to the predicate.

Contents (Acceptance Criteria / Parameter to be met)	Subject Device (Reported Device Performance)	Predicate Device (Target for equivalence)	SE (Outcome of Meeting Criteria)
Basic Characteristic
Trade Name	TENS & EMS Device	HIVOX OTC Electrical Stimulator	SE
Device Model	FM-B2403	SEM44	/ (Not a direct SE comparison, just identifies)
Regulatory Information	882.5890, 890.5850	882.5890, 890.5850	/ (Indicates equivalent regulatory classification)
Classification	Class II	Class II	/
Product code	NUH, NGX	NUH, NGX	/
Panel	Physical Medicine; Neurology	Neurology; Physical Medicine	/
OTC/RX	OTC	OTC	/
Intended Use	(Identical descriptions for TENS and EMS)	(Identical descriptions for TENS and EMS)	SE
Apply parts of the body	Shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom	Shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom	SE
Power Source	Built-in 3.7V lithium battery	Batteries, 3x1.5V AAA	SE (Functionally equivalent despite different battery type)
Number of Output Modes	TENS:19, EMS:5	TENS: 15 EMS: 35	SE (Different numbers, but still acceptable for equivalence)
Number of Output Channels	4	2	SE (More channels is not considered a disadvantage for equivalence)
Synchronous or Alternating	Synchronous	Synchronous	SE
Method of Channel Isolation	By electrical circuit and software	By electrical circuit and software	SE
Regulated Current or Regulated Voltage	Regulated voltage control	Regulated voltage control	SE
Software/Firmware/Microprocessor Control?	Yes	Yes	SE
Automatic Overload Trip?	No	Yes	SE (Difference noted, but deemed non-critical for substantial equivalence)
Automatic No-Load Trip?	No	Yes	SE (Difference noted, but deemed non-critical for substantial equivalence)
Automatic Shut Off?	Yes	Yes	SE
Patient Override Control?	Yes	Yes	SE
Indicator Display?	Yes	Yes	SE
Timer Range (minutes)	10-80	5-100	/ (Acceptable range difference for equivalence)
Compliance with Voluntary Standards?	ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10	IEC60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10	SE
Compliance* with 21 CFR 898?	Yes	Yes	SE
Weight(g)	82 g	89 g (including belt clip, without batteries), 123 g (including belt clip and batteries)	SE
Dimensions (mm) [D x W H]	1106015	132 x 63 x 29.5 mm (including belt clip)	SE
Housing Materials and Construction	ABS	ABS	SE
Output Parameters			(Comparison to Predicate and often to a second predicate for broader range acceptance)
Waveform	biphasic	biphasic	SE
Shape	Square	Square / Rectangular (Second Predicate)	SE
Maximum Output Voltage (volts) (+/- 10%)	97.6@500Ω, 135@2KΩ, 157@10KΩ	100volts peak-peak±10%@500Ω, 180volts peak-peak±10%@2kΩ, 250volts peak-peak±10%@10KΩ; 62@500Ω (Second Pred.)	SE
Maximum Output Current (mA) (+/- 10%)	195.2@500Ω, 67.5@2KΩ, 15.7@10KΩ	200mA peak-peak±10% @500Ω, 90mA peak-peak±10% @2kΩ, 25mA peak-peak±10% @10kΩ; 124@500Ω, 37.6@2KΩ (Second Pred.)	SE
Pulse Duration (µsec)	90µS	50-450µS; 100µS (Second Pred.)	SE
Frequency† (Hz) [or Rate† (pps)]	< 90.9Hz	1-150Hz; 61Hz (Second Pred.)	SE
Net Charge (micro coulombs (µC) per pulse)	0.001@500Ω	0.001@500Ω; 0 (Second Pred.)	SE
Maximum Phase Charge, (µC)	15.5@500Ω	45@500Ω; 17.92µC (Second Pred.)	SE
Maximum Current Density(mA/cm2)	0.1192@500Ω	0.667@500Ω; 9.95 mA/cm² (Second Pred.)	SE
Maximum Power Density(mW/cm2)	0.176@500Ω	4.6@500Ω; 2.7 (Second Pred.)	SE
Pulses per burst	2	3; Not publicly available (Second Pred.)	SE
Bursts per second	1/30	2/60; Not publicly available (Second Pred.)	SE
Burst duration (ms)	45	36; Not publicly available (Second Pred.)	SE
Duty Cycle: Line (b) x Line (%)	0.016	36ms/390ms; Not publicly available (Second Pred.)	SE
ON Time (seconds)	1	2; Not publicly available (Second Pred.)	SE
OFF Time (seconds)	1	2; Not publicly available (Second Pred.)	SE
Standard/Guidance Document Referenced	As listed	As listed; Not publicly available (Second Pred.)	SE

2. Sample sized used for the test set and the data provenance

This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance evaluation with patient data. The "testing" refers to engineering and electrical performance testing of the device itself.

Sample Size: Not applicable in the sense of patient data. The testing would typically involve a specific number of manufactured devices, but this is not detailed in the summary as it's part of the manufacturer's internal quality control and verification activities to ensure each device meets specifications.
Data Provenance: The device is manufactured by Shenzhen Jianfeng Electronic Technology Co., Ltd. in China. The testing data would be generated from their internal labs or third-party testing facilities engaged by the manufacturer, verifying the device's electro-physical properties against the stated specifications and international standards (e.g., IEC 60601 series). This is prospective testing of the manufactured device.

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

Not applicable for this type of medical device submission. Ground truth, in this context, relates to clinical diagnoses or outcomes, which are not evaluated for this device's substantial equivalence. The "ground truth" for this device is its adherence to engineering specifications and safety standards as measured by accredited test methods, performed by qualified engineers and technicians.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical datasets, particularly for image-based diagnostic AI, where human expert consensus is needed to define a true positive/negative. This process is not part of a regulatory submission for a TENS/EMS device.

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 not an AI or imaging diagnostic tool, so no MRMC study or AI assistance evaluation was performed. The device delivers electrical stimulation for pain relief and muscle performance.

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

Not applicable. This is a physical Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device, not an algorithm. Its performance is evaluated based on its electrical output parameters, safety, and physical characteristics.

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

The "ground truth" for this device's clearance is its compliance with established electrical and safety standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and its functional equivalence to a legally marketed predicate device. This is determined through:

Measured Electrical Output Parameters: Verification that its output voltage, current, pulse duration, frequency, etc., fall within acceptable ranges and are comparable to the predicate device.
Safety Testing: Demonstrating compliance with electrical safety (e.g., against electric shock hazards, EMC), mechanical safety, and biocompatibility standards.
Performance Verification: Ensuring the device operates as intended for TENS and EMS functionalities.

This is fundamentally different from a clinical "ground truth" derived from patient outcomes or expert diagnoses.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, no training set is involved.

Summary

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Image /page/0/Picture/0 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 19, 2021

SHenzhen Jianfeng Electronic Technology Co., Ltd. % Iris Lin Account Manager Intertek Testing Services Shenzhen Ltd. Guangzhou. Block E, No.7-2 Guangdong Software Science Park, Caipin Road Guangzhou Science City, GETDD, Guangdong 510700 China

Re: K202866

Trade/Device Name: TENS & EMS 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: February 24, 2021 Received: March 2, 2021

Dear Iris Lin:

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

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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,

For 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

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Indications for Use

510(k) Number (if known)

K202866

Device Name TENS and EMS Device

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)

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510(k) Summary

K202866

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: May-11-2021
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, 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 Jialinqyu Industrial Building, Da Pu Road, Houting Village, Shajing Town, Baoan District, Shenzhen City, Guangdong Province, China.

Contact Person: Feng Wen

Title: General Manager

Email: wenfeng@fzjhealth.com

Tel: +86-755-33858361 Fax: +86-755-33858360

3. The Predicate Device Information

Basic Information	Predicate Device
Manufacturer	HIVOX BIOTEK INC.
Device Name and Model	HIVOX OTC Electrical StimulatorSEM44
510(k) Number	K171803
Product Code	NUH, NGX
Panel Code	Physical Medicine, Neurology
Regulation Number	21 CFR 882.589021 CFR 890.5850
Regulation Class	Class II

4. Subject Device Information

Trade Name: TENS & EMS Device

Common Name: TENS, EMS, Stimulator for pain relief;

Classification Name: Powered muscle stimulator; Transcutaneous electrical nerve stimulator for pain

relief; Nerve muscle stimulator

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Review Panel: Physical Medicine; Neurology Product Code: NUH, NGX Regulation Number: 21CFR882.5890, 21CFR890.5850 Device Classification: Class II Use: Over-the-Counter Use (OTC)

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.

7. Technological characteristics and substantial equivalence

7.1 The following table is the basic characteristic:

Contents	Subject Device	Predicate Device	SE
Trade Name	TENS & EMS Device	HIVOX OTC Electrical Stimulator	SE
Device Model	FM-B2403	SEM44	/
510(k) Number	K202866	K171803	/
Manufacturer	Shenzhen Jian Feng ElectronicTechnology Co., Ltd.	HIVOX BIOTEK INC.	/
		1) 882.5890
Regulatory Information	882.5890, 890.5850	2) 890.5850	/
Classification	Class II	Class II	/
Product code	NUH, NGX	NUH, NGX	/
Panel	Physical Medicine; Neurology	1) Neurology2) Physical Medicine	/
OTC/RX	OTC	OTC	/
Intended Use	TENS: The device is designed to beused for temporary relief of painassociated with sore and achingmuscles in the shoulder, waist, back,neck, upper extremities (arm), lowerextremities (leg), abdomen andbottom due to strain from exercise ornormal household work activities.EMS: The device is designed to beused to stimulate healthy muscles inorder to improve or facilitate muscleperformance.	TENS: The device is designed to beused for temporary relief of painassociated with sore and achingmuscles in the shoulder, waist,back, neck, upper extremities (arm),lower extremities (leg), abdomenand bottom due to strain fromexercise or normal household workactivities.EMS: The device is designed to beused for stimulate healthy musclesin order to improve and facilitatemuscle performance.	SE
Apply parts of the body	Shoulder, waist, back, neck, upperextremities (arm), lower extremities(leg), abdomen and bottom	Shoulder, waist, back, neck, upperextremities (arm), lower extremities(leg), abdomen and bottom	SE
Power Source	Built-in 3.7V lithium battery	Batteries, 3x1.5V AAA	SE
Number of Output Modes	TENS:19, EMS:5	TENS: 15 EMS: 35	SE
Number of Output Channels	4	2	SE
Synchronous or Alternating	Synchronous	Synchronous	SE
Method of Channel Isolation	By electrical circuit and software	By electrical circuit and software	SE
Regulated Current orRegulated Voltage	Regulated voltage control	Regulated voltage control	SE
Software/Firmware/Microprocessor Control?	Yes	Yes	SE
Automatic Overload Trip?	No	Yes	SE
Automatic No-Load Trip?	No	Yes	SE
Automatic Shut Off?	Yes	Yes	SE
Patient Override Control?	Yes	Yes	SE
Indicator Display?On/Off Status?Low Battery?Voltage/Current Level?	Yes	Yes	SE
Timer Range (minutes)	10-80	5-100
Compliance with VoluntaryStandards?	ANSI/AAMI/ES 60601-1IEC60601-1-2IEC 60601-2-10IEC60601-1-11ISO10993-5ISO10993-10	IEC60601-1IEC60601-1-2IEC 60601-2-10IEC60601-1-11ISO10993-5ISO10993-10	SE
Compliance* with 21 CFR898?	Yes	Yes	SE
Weight(g)	82 g	89 g (including belt clip, withoutbatteries),123 g (including belt clip andbatteries)	SE
Dimensions (mm) [D x W H]	1106015	132 x 63 x 29.5 mm(including belt clip)	SE
Housing Materials andConstruction	ABS	ABS	SE
Contents	Subject Device	Predicate Device	Additional-PredicateDevice	SE
Device Name, Model	FM-B2403	SEM44	JQ-5C	/
Waveform (e.g., pulsedmonophasic, biphasic)	biphasic	biphasic	biphasic	SE
Shape (e.g., rectangular,spike, rectified sinusoidal)	Square	Square	Rectangular	SE
Maximum Output Voltage(volts) (+/- 10%)	97.6@500Ω135@2KΩ157@10KΩ	100volts peak-peak±10%@500Ω180volts peak-peak±10%@2kΩ250volts peak-peak±10%@10KΩ	62@500Ω	SE
Maximum Output Current(mA) (+/- 10%)	195.2@500Ω67.5@2KΩ15.7@10KΩ	200mA peak-peak±10% @500Ω90mA peak-peak±10%@2kΩ25mA peak-peak±10%@10kΩ	124@500Ω37.6@2KΩ	SE
Pulse Duration (µsec)	90µS	50-450µS	100µS	SE
Frequency† (Hz) [orRate† (pps)]	< 90.9Hz	1-150Hz	61Hz	SE
Net Charge (microcoulombs (µC) per pulse)(If zero, state method ofachieving zero netcharge.)	0.001@500Ω	0.001@500Ω	0	SE
Maximum Phase Charge,(µC)	15.5@500Ω	45@500Ω	17.92µC	SE
Maximum CurrentDensity(mA/cm2)	0.1192@500Ω	0.667@500Ω	9.95 mA/cm²	SE
Maximum PowerDensity(mW/cm2)	0.176@500Ω	4.6@500Ω	2.7	SE
Pulses per burst	2	3	Not publicly available	SE
Bursts per second	1/30	2/60	Not publicly available	SE
Burst duration (ms)	45	36	Not publicly available	SE
Duty Cycle: Line (b) x Line(%)	0.016	36ms/390ms	Not publicly available	SE
ON Time (seconds)	1	2	Not publicly available	SE
OFF Time (seconds)	1	2	Not publicly available	SE
Standard/GuidanceDocument Referenced	ANSI/AAMI/ES 60601-1IEC60601-1-2IEC60601-1-11IEC 60601-2-10ISO 10993-5:2009ISO 10993-10:2010	IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO10993-5/10	Not publicly available	SE

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7.2The following table is the output parameters:

8. Non-Clinical Tests Performed

Compliance to applicable voluntary standards include: ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11.

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

9. Conclusion:

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the EMS and TENS Devices (Model FM-B2403) is substantially equivalent to the predicate device (Model: SEM44).

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).