The FD2050 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Description

The FD2050 is a handheld battery powered TENS device. which is used for pain relief. The device would generate electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

FD2050 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the FD2050 (Slide TENS) device, comparing it to a predicate device (SMART TENS). This document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study designed to establish acceptance criteria for a novel device's performance in a clinical setting.

Therefore, many of the requested categories for a study proving device performance (such as sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established for the training set) are not applicable or not available in this type of regulatory submission. This document confirms the device's technical specifications and safety compliance.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the predicate device's specifications and compliance with relevant safety and EMC standards. The "reported device performance" is a comparison of the FD2050's output specifications against those of the predicate device.

Parameter	Acceptance Criteria (Predicate Device: SMART TENS - K091045)	Reported Device Performance (FD2050 / Slide TENS - K111645)
Waveform	Asymmetrical Bi-Phasic Rectangular Waveform	Asymmetrical Bi-Phasic Rectangular Waveform
Max Voltage	61V @500Ω, 76V @2kΩ, 90V @10kΩ	60V @500Ω, 75V @2kΩ, 83V @10kΩ
Max Output Current	122 mA @500Ω, 38 mA @2kΩ, 9 mA @10kΩ	120 mA @500Ω, 37 mA @2kΩ, 8 mA @10kΩ
Max Pulse Width	250 μs	250 μs
Max Frequency	100Hz	150Hz
Max Output Charge Per Phase	28.4μC @500Ω, 21.3μC @1kΩ, 13.9μC @2kΩ, 3.9μC @10kΩ	23.0μC @500Ω, 17.1μC @1kΩ, 11.9μC @2kΩ, 3.4μC @10kΩ
Max Output Net Charge Per Phase	14.4μC @500Ω, 6.5μC @1kΩ, 2.9μC @2kΩ, 0.4μC @10kΩ	11.9μC @500Ω, 6.2μC @1kΩ, 2.9μC @2kΩ, 0.4μC @10kΩ
Max Output RMS Current	14.4 mArms @500Ω, 10.0 mArms @1kΩ, 6.3 mArms @2kΩ, 1.7 mArms @10kΩ	13.1 mArms @500Ω, 8.4 mArms @1kΩ, 5.3 mArms @2kΩ, 1.4 mArms @10kΩ
Max Current Density	0.11 mA/cm2 @500Ω	0.22mA/cm2 @500Ω
Max Power Density	4.2 mW/cm2 @500Ω	5.3 mW/cm2 @500Ω
Treatment Timer	5 selectable times (Continuous, 15, 30, 45, 60 min)	5 selectable times (Continuous, 15, 30, 45, 60 min)
Continuous Stimulation (CONTS)	100Hz, selectable 20µs to 250µs	150µs, Selectable 1Hz to 150Hz
Burst (BURST 1 & 2)	32Hz, selectable 20µs to 250µs, 2 burst/sec, 7 pulses/burst	Burst 1: 28Hz, 150µs, 2 bursts/sec, 7 pulses/burst; Burst 2: 80Hz, 150µs, 1 burst/2sec, 80 pulses/burst
Pulse Width Modulation (MODUL 1)	20µs -> max pulse width in 5 sec, max pulse width ->20µs in 5sec, repeat; 23 selectable max pulse width	50µs -> 250µs in 6sec, 250µs -> 50µs in 6sec, repeat; 42 selectable pulse rate
Frequency Modulation (MODUL 2)	Not Available	Pulse width 150µs, 20Hz -> 100Hz in 6sec, 100Hz -> 20Hz in 6sec, repeat

Note on Differences: While many parameters are similar, some show differences (e.g., Max Frequency, Max Current Density, Max Power Density, and specific modulation programs). The submission argues these differences do not raise new questions of safety or effectiveness, as the overall electrical stimulus characteristics remain within generally accepted ranges for TENS devices.

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

Not applicable. This submission is a 510(k) for a TENS device, which typically relies on demonstrating substantial equivalence to a predicate device through engineering similarity, performance testing (bench testing), and compliance with recognized standards. It does not involve human subject testing to establish efficacy or safety from a "test set" of patients or data in the way a diagnostic AI device would.
The data provenance mentioned (e.g., country of origin, retrospective/prospective) is not relevant in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No clinical ground truth from human experts was established for this type of device. The ground truth for performance is the technical specifications and safety standards.

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

Not applicable. No clinical adjudication was performed as part of this 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 is a hardware medical device (TENS) and does not involve AI or human "readers" (e.g., radiologists, pathologists). Therefore, MRMC studies are not relevant.

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

Not applicable. This device is a TENS unit. While it contains software, its "performance" is its ability to generate specific electrical pulses, not to perform an algorithmic diagnosis or interpretation. Its functionality is inherently "standalone" in generating the electrical output once parameters are set by the user, but this term is not used in the context of standalone AI performance.

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

The "ground truth" for this device's acceptance is its compliance with recognized electrical safety and EMC standards (EN60601-1, EN60601-1-2) and its technical electrical output specifications which are compared to a legally marketed predicate device. Additionally, biocompatibility testing was performed on the material (ABS) to ensure safety.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

Not applicable. No training set was used.

Summary

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NOV - 9 2011

510(k) Summary (per 21 CFR 807.92) E.

Device 510(k) number: K111645

Applicant Information 1.

Date Prepared: Oct 7, 2011

Fuji Dynamics Ltd. Submitter: Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road, Kowloon Hong Kong

LEE, Ching Kong Felix Contact Person: (852) 2786 4218 Tel:

Tel:	(852) 2733 7272
Fax:	(852) 2744 6775

General Device Information 2.

Model Number:	FD2050
Trade Name:	Slide TENS
	FD TENS 2050
Common Name:	Transcutaneous Electric Nerve Stimulator
Product Code:	GZJ
Classification:	Class II

3. Predicate Device Information:

SMART TENS [510(k) No.: K091045]

4 Device Description

General

FD2050 has two output channels and five preset programs. The program mode is displayed on a LCD. The user can adjust the output intensity by 20 steps.

Software

The software is built up with different software modules. The software modules are interconnected. One software module can be activated by another software module. The hardware is the physical interface to the user. The hardware passes or receives signal to or from the controller..

Operation (refer the Functional Block)

The microcontroller (MCU) takes request from the key pad (H2). It determines the logic and the parameter setting. It displays the information to the LCD (H1). The output intensity is directly related to the output voltage. The device makes use of a boost converter (H4) such that the controller sends different numbers of pulses to the boost converter build up desired amount of charges. The charges are released through a transistor bridge circuit (H5). The controller manipulates the pulse width, timing and polarity of the pulses in different program modes.

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When battery gets dry, there is signal from voltage detection chip (H3) and the controller reflects the status on the screen by turning on an icon.

The open circuit detect circuitry (H6) can sense if electrode is detached. The controller reflects the status on the screen and turn down the output intensity.

Device Safeguards

Software Malfunction – watch dog timer is used to safeguard the malfunction or dead lock of software. The watch dog timer counts down to zero in 546ms. The software in the main loop resets and restarts the timer. If the microcontroller experiences deadlock in subroutine and cannot return to the main loop within 546ms, the device will be turned off and intensity level will be down to zero.

Shock Protection - the circuitry has the open circuit detection to prevent user from getting shock. It recognizes 500 to 20k ohm as the present of load and above 200k ohm to be open load. If the electrodes are physical detached from the device, the device will turn down the level to zero.

Battery Low - a voltage detection chip is used to monitor the voltage level. If the voltage drops below a threshold, it signals the microcontroller to alert the patient by displaying an icon.

5 Intended Use:

FD2050 is intended to use as

Symptomatic relief and management of chronic intractable pain .
Adjunctive treatment for the management of post-traumatic or post-surgical . pain.

Comparison to Predicate Device: 6

Similarity

Engineering

FD2050 is developed on the same platform as Smart TENS.

On hardware, the schematic and the use of electronics components are the same. The software is cloned from Smart TENS so the basic mechanism, like the basic timing, key scanning and generation of pulse are the same.

Intended Use

FD2050 is intended to be a Transcutaneous Electrical Nerve Stimulator, same as Smart TENS.

Biocompatibility

The polymer ABS of the biocompatibility test article is identical to the ABS of the final device in formulation, processing , and cleaning, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).

Difference

Since the shape of FD2050 is different from Smart TENS, the PC boards are different between two devices. The software basically the same while the parameters for treatment programs are changed so they have different treatment programs.

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Functional Block

Image /page/2/Figure/3 description: The image shows a block diagram of a system with several components. The central component is labeled "MCU", and it is connected to several other components, including "LCD (H1)", "Key Pad (H2)", "Battery Low Detect (H3)", "Voltage Boost (H4)", "Output Circuit (H5)", and "Open Circuit Detect (H6)". Arrows indicate the direction of communication between the components, suggesting a flow of information and control within the system.

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Output Specification Comparison

Parameter	FD2050 / Slide TENSK111645	SMART TENSK091045 (Predicate Device)
Waveform	Asymmetrical Bi-PhasicRectangular Waveform	Asymmetrical Bi-PhasicRectangular Waveform
Maximum Voltage(0 to peak voltage)	60V @500Ω75V @2kΩ83V @10kΩ	61V @500Ω76V @2kΩ90V @10kΩ
Max Output Current	120 mA @500Ω37 mA @2kΩ8 mA @10kΩ	122 mA @500Ω38 mA @2kΩ9 mA @10kΩ
Maximum Pulse Width	250 μs	250 μs
Maximum Frequency	150Hz	100Hz
Maximum OutputCharge Per Phase	* 23.0μC @500Ω17.1μC @1kΩ11.9μC @2kΩ3.4μC @10kΩ	28.4μC @500Ω21.3μC @1kΩ13.9μC @2kΩ3.9μC @10kΩ
Maximum OutputNet Charge Per Phase	* 11.9μC @500Ω6.2μC @1kΩ2.9μC @2kΩ0.4μC @10kΩ	14.4μC @500Ω6.5μC @1kΩ2.9μC @2kΩ0.4μC @10kΩ
Maximum OutputRMS Current	* 13.1 mArms @500Ω8.4 mArms @1kΩ5.3 mArms @2kΩ1.4 mArms @10kΩ	14.4 mArms @500Ω10.0 mArms @1kΩ6.3 mArms @2kΩ1.7 mArms @10kΩ
Max Current Density	* 0.22mA/cm2 @500Ω	0.11 mA/cm2 @500Ω
Max Power Density	* 5.3mW/cm2 @500Ω	4.2 mW/cm2 @500Ω
Treatment Timer	5 selectable timerContinuous 15 minutes30 minutes 45 minutes60 minutes	5 selectable timerContinuous 15 minutes30 minutes 45 minutes60 minutes
Continuous Stimulation(CONTS)	150µsSelectable 1Hz to 150Hz	100HzSelectable 20µs to 250µs
Burst(BURST 1BURST 2)	Burst 128Hz, 150µs, 2 bursts/sec, 7pulses/burstBurst 280Hz, 150µs, 1 burst/2sec, 80pulses/burst	32Hz, selectable 20µs to 250µs2 burst/sec, 7 pulses/burst
Pulse Width Modulation(MODUL 1)	50µs -> 250µs in 6sec250µs -> 50µs in 6secrepeat	20µs -> max pulse width in 5 secmax pulse width ->20µs in 5secrepeat
	42 selectable pulse ratebetween 1Hz and 150Hz	23 selectable max pulse widthbetween 20µs and 250µs
Frequency Modulation(MODUL 2)	Pulse width 150µs20Hz -> 100Hz in 6sec100Hz -> 20Hz in 6secThen repeat	Not Available

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K11645

* Sample Calculation

Image /page/4/Figure/3 description: This image contains a graph and several equations related to electrical charge and current density. The graph shows voltage over time, with labels such as V1, V2, t1, and t2. Several equations are presented, including formulas for V(t), τ, and Q, along with calculations for Q+ and Q- which are 17.44 μC and 5.51 μC, respectively. The image also includes calculations for MaxCharge, NetCharge, and CurrentDensity, with the final current density calculated as 0.22mA/cm².

$$I_{rms}^2 = \frac{1}{T} \int_{t_i}^{t_f} \left(\frac{\mathbf{V}_1}{R_L} \mathbf{e}^{-\left(\mathbf{t} - \mathbf{t}_i\right)/\tau}\right)^2 dt = \frac{\tau}{2T} \left(\frac{\mathbf{V}_1}{R_L}\right)^2 \left(\mathbf{l} \cdot \mathbf{e}^{-\epsilon_s/\tau}\right)$$

$$I_{rms}^{2} = \frac{208\mu s}{2(1/150Hz)} \left(\frac{60V}{500\Omega}\right)^{2} (1 - e^{-250\mu s / 208\mu s}) = 0.157 lmA^{2}$$

$$+ve Pulse I_{rms}^{2} = 0.1571mA^{2}$$

$$-ve Pulse I_{rms}^{2} = 0.0132mA^{2}$$

$$I_{rms} = \sqrt{0.1571mA^{2} + 0.0132mA^{2}} = 13.1mA$$

$$MaxPowerDensity = \frac{Effective Power}{Area of Electrode} = \frac{\sum (I_{rms}^{2} \cdot R_{L})}{A}$$

$$= \frac{(0.1571 + 0.0132)mA^{2} \cdot 500\Omega}{4cm \cdot 4cm} = 5.3 mW/cm^{2}$$

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E. 510(k) Summary (per 21 CFR 807.92)

7 Non-clinical Testing:

FD2050 complies with the following standard. EN60601-1 Safety requirement EN60601-1-2 EMC requirements

The design control follows the FDA quality system requirement and the software verification has been carried out according to the FDA software guidance.

8 Clinical Testing

None

9 Conclusions:

FD2050 has the same intended use and the same technical characteristics as the predicate device, SMART TENS [510(k) No.: K091045].

FD2050 is as safe and as effective as the predicate device.

Therefore, the FD2050 is substantially equivalent to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

Fuji Dynamics, Ltd. c/o Mr. Ching Kong Lee Product Developer Manager Unit 1-3, 23/F, Laws Commercial Plaza 788 Cheung Sha Wan Road Kowloon, Hong Kong

NOV - 9 2011

Re: K111645

Trade/Device Name: Slide TENS FD TENS 2050 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: October 11, 2011 Received: October 12, 2011

Dear Mr. Lee:

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.

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Page 2 - Mr. Ching Kong (Felix) Lee

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely yours.

Kesia Alexander

Image /page/7/Picture/7 description: The image shows the handwritten word "for" in cursive script. The letter 'f' has a large, looping descender that extends below the baseline, and the 'o' and 'r' are connected with a smooth, flowing line. The writing style appears elegant and fluid.

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K111645 . · 510(k) Number (if known):

FD2050 Model No.: FD TENS 2050 Device Name: Slide TENS

Indications For Use:

The FD2050 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dan L. Kaufman, M.A.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K111645

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).