Who is the manufacturer of FD TENS 2070?

Fuji Dynamics , Ltd. filed the 510(k) submission for FD TENS 2070 (K111654).

What is the FDA product code for FD TENS 2070?

GZJ. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for FD TENS 2070?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like FD TENS 2070?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FD TENS 2070

K111654 · Fuji Dynamics , Ltd. · GZJ · Mar 1, 2012 · Neurology

Device Facts

Record ID	K111654
Device Name	FD TENS 2070
Applicant	Fuji Dynamics , Ltd.
Product Code	GZJ · Neurology
Decision Date	Mar 1, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of chronic post-surgical and post-traumatic acute pain.

Device Story

The FD2070 (Mini TENS) is a single-channel Transcutaneous Electrical Nerve Stimulator (TENS) unit. It generates electrical pulses transmitted to electrodes attached to the skin, which stimulate underlying peripheral nerves to block pain signals traveling to the brain. The device is operated by the user for pain management. It features a microcontroller-based system that delivers symmetrical bi-phasic rectangular pulses. The user selects from various burst and modulation programs to manage pain. The device is intended for symptomatic relief of chronic intractable pain and as an adjunctive treatment for chronic post-surgical and post-traumatic acute pain.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (EN60601-1) and EMC (EN60601-1-2) compliance, and software verification per FDA guidance.

Technological Characteristics

Single-channel TENS unit; symmetrical bi-phasic rectangular waveform; max voltage 39V @10kΩ; max frequency 120Hz; max pulse width 333μs. Materials: ABS polymer. Connectivity: None. Power: Battery-operated. Software: Microcontroller-based, rule-based logic.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain and as adjunctive treatment for chronic post-surgical and post-traumatic acute pain.

Regulatory Classification

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.

Predicate Devices

FD TENS 2030 (K052813)

Submission Summary (Full Text)

{0}------------------------------------------------ # MAR - 1 2012 ### E. 510(k) Summary (per 21 CFR 807.92) Device 510(k) number: K111654 #### Applicant Information 1. | Date: | Feb 8, 2012 | |-----------------|---------------------------------------------------------------------------------------------------------------| | Submitter: | Fuji Dynamics Ltd. Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road, Kowloon Hong Kong | | Contact Person: | NG, Kam Tim Product Development Manager | | Tel: Fax : | (852) 2786 4218 (852) 2744 6775 | ### 2. General Device Information | Model No.: | FD2070 | |-----------------|-------------------------------------------------| | Trade Name: | Mini TENS | | | FD TENS 2070 | | Common Name: | Transcutaneous Electric Nerve Stimulator (TENS) | | Product Code: | GZJ | | Classification: | Class II | ### 3. Predicate Device Information: FD2070 is substantially equivalent to FD TENS 2030 (K052813) which is also manufactured by Fuji Dynamics. manufactured by Fuji Dynamics. #### 4. Device Description As a Transcutanous Electrical Nerve Stimulator (TENS) unit, FD2070 generates patientical pulses and transmit it to the electrodes, within clectical pulses and transmit it to the electrodes, which are attached in the skin to the underlying peripheral pulses would then pass his gold then pass through the unders skin to the underlying peripheral nerves no aid in the pass through the skin to the underlying peripheral nerves to aid in the blocking to the traveling to the brain. #### Intended Use: 5 FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of chronic post-surgical and post-traumatic acute nain post-surgical and post-traumatic acute pain. {1}------------------------------------------------ #### Comparison to Predicate Device: ( ### Similarity Engineering Both FD2070 and FD TENS 2030 are developed by Fuji with the similar platform and technology platform and technology. Although the microcontrollers used are both devices are different, the software flow, the software logic and the modules are similar. On hardware, the basic mechanisms generating the pulses are the same. - ### Intended Use FD2070 is intended to be a Transcutaneous Electrical Nerve Stimulator, same as FD TENS 2030. FD TENS 2030. ### Biocompatibility The polymer ABS of the biocompatibility test article is identical to the ABS of the predicate device (FD TENS 2030, K052813) 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 FD2070 is single channel but FD TENS 2030 is two channels, the electronics hardware are different. The treatment programs are also different. {2}------------------------------------------------ | Characteristic | FD2070 / Mini TENS K111654 | FD TENS 2030 K052813 (Predicate Device) | |--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Waveform | Symmetrical Bi-Phasic | Asymmetrical Bi-Phasic | | Shape | Rectangular | Rectangular | | Maximum Voltage (peak voltage) | 30V @500Ω 37V @2KΩ 39V @10KΩ | 31V @500Ω 51V @2KΩ 85V @10KΩ | | Max Output Current (peak current) | 60mA @500Ω 18mA @2KΩ 4mA @10KΩ | 63mA @500Ω 25 mA @2KΩ 9 mA @10KΩ | | Maximum Pulse Width | 333 μs | 250μs | | Maximum Frequency | 120Hz | 200Hz | | Maximum Net Charge Per Pulse | * 0.5μC @500Ω | 5.8μC @500Ω | | Maximum Output Charge Per Phase | * 15.3μC @500Ω | 15.8μC @500Ω | | Maximum Output RMS Current | ** 6.0 mA rms @500Ω | 11.0 mA rms @500Ω | | Max Current Density | ** 0.074 mA/cm² | 0.1 mA/cm² | | Max Power Density | ** 1.12 mW/cm² | 1.82 mW/cm² | | BURST 1 | Burst 1 (Step 1) 80Hz 240pulses/burst, 1 burst/6sec 3 sec duration, 50% duty cycle Burst 1 (Step 2) 60Hz 240pulses/burst, 1 burst/8sec 4 sec duration, 50% duty cycle Burst 1 (Step 3) 100Hz 300pulses/burst, 1 burst/6sec 3 sec duration, 50% duty cycle | BURST I 80Hz Selectable pulse width between 25us and 250us 80pulses/burst, 1 burst/2sec 1 sec duration, 50% duty cycle Selectable pulse width | | BURST 2 | Burst 2 (Step 1) 60Hz 180pulses/burst, 1 burst/6sec 3 sec duration, 50% duty cycle Burst 2 (Step 2) 80Hz 80pulses/burst, 1 burst/2sec 1 sec duration, 50% duty cycle Burst 2 (Step 3) 100Hz 100pulses/burst, 1 burst/2sec 1 sec duration, 50% duty cycle | BURST II 28Hz Selectable pulse width between 25us and 250us 7pulses/burst, 2 burst/sec 1 sec duration, 50% duty cycle | | BURST 3 | Burst 3 (Step 1) 4Hz 96pulses/burst, 1 burst/28sec 24 sec duration, 85.7% duty cycle Burst 3 (Step 2) 60Hz 120pulses/burst, 1 burst/2.5sec 2 sec duration, 80% duty cycle Burst 3 (Step 3) 80Hz, 250us Amplitude Modulation 2.5Hz, 50% On 40sec, Off 4sec | | ### E. 510(k) Summary (per 21 CFR 807.92) {3}------------------------------------------------ | Continuous Mode | Not available | Selectable 1Hz to 200Hz Selectable 25μs to 100μs | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | Pulse Width Modulation | Not available | Selectable 1Hz to 200 Hz 25μs to 250μs in 8 sec 250μs to 15μs in 8sec, repeat | | Frequency Modulation | Not available | Selectable 25μs to 250μs 100Hz to 20 Hz in 8 sec, 20Hz to 100Hz in 8sec, repeat | | MODUL 1 (Modulation 1) | Modulation 1 (Step 1) 100Hz, 200μs 0.5Hz, 50% On 42sec, Off 6sec Modulation 1 (Step 2) 80Hz, 250μs 2Hz, 30% On 4sec, Off 4sec Modulation 1 (Step 3) 60Hz, 333μs 1.25Hz, 30% On 4sec, Off4sec | | | MODUL 2 (Modulation 2) | Modulation 2 (Step 1) 100Hz, 200μs 0.5Hz, 50% On 38sec, Off 4sec Modulation 2 (Step 2) 80Hz, 250μs 1.25Hz, 40% On 8sec, Off 4sec Modulation 2 (Step 3) 120Hz, 167μs 1.25Hz, 40% On 8sec, Off 4sec | | | MODUL 3 (Modulation 3) | Modulation 3 (Step 1) 120Hz, 167μs 0.5Hz, 50% On 40sec, Off 4sec Modulation 3 (Step 2) 100Hz, 120μs 0.25Hz, 50% On 36sec, Off 4sec Modulation 3 (Step 3) 80Hz, 250μs 0.125Hz, 50% | | ### E. 510(k) Summary (per 21 CFR 807.92) {4}------------------------------------------------ # * Sample Calculation – using Burst 3 (Step 1) Image /page/4/Figure/2 description: The image shows two graphs, one for a positive pulse and one for a negative pulse, along with calculations related to charge and time constants. The positive pulse graph shows voltage over time, with labels V1, V2, t1, and t2. Calculations determine $ \tau_+ $ as 139 $ \mu s $, $ Q_+ $ as 7.88 $ \mu C $, $ \tau_- $ as 142 $ \mu s $, and $ Q_- $ as 7.41 $ \mu C $. The maximum charge per phase is calculated as 15.3 $ \mu C $, and the maximum net charge per phase is 0.5 $ \mu C $. {5}------------------------------------------------ ** Sample Calculation – using Burst 1 (Step 3) $$\left[\boldsymbol{I}\right]_{rms}^{2} = \frac{1}{T} \int_{t_{\parallel}}^{t_{\perp}} \left(\frac{\dot{\boldsymbol{V}}_{1}}{\boldsymbol{R}_{L}} \cdot \mathbf{e}^{-\left(\boldsymbol{l} - \boldsymbol{t}_{\perp}\right)/\tau}\right)^{2} d\boldsymbol{t} = \frac{\pi}{2T} \left(\frac{\mathbf{V}_{1}}{\boldsymbol{R}_{L}}\right)^{2} \left(\boldsymbol{l} - \boldsymbol{e}^{-t_{\perp}/\tau}\right) \dots \text{(iii)}$$ From equation (3), (4) and (iii) above Positive Pulse $-202 \mu s$ $\tau_{+}$ $=123\mu s$ Equation (3) 6.0V ln 31.2V Equation (4) $\frac{31.2V \cdot 123\mu s}{}$ [ $Q_{+} =$ $- e^{-202 \mu s / 123 \mu s}$ ] = 6.18$\mu C$ $Q_{-} = 5.66 \mu C$ 500$\Omega$ 123$\mu s$ $I_{rms}^{2} =$ 31.2V $e^{-202 \mu s / 123 \mu s}$ Equation (iii) 2(1/100Hz) 500Ω $I_{rms}^2 = 0.0165mA^2$ = 0.0193$mA^2$ Negative Pulse $τ$ = 120$\mu s$ $$I_{rms} = \sqrt{0.0193mA^{2} + 0.0165nA^{2}} = 6.0mA$$ $$CurrentDensity = \frac{Q_{+} + Q_{-}}{period \cdot area} = \frac{11.8\mu C}{(1/100Hz) \cdot (4cm \times 4cm)} = 0.074mA/cm^{2}$$ $$\frac{Effective \ Power}{Area \ of \ Electrode} = \frac{\sum (I_{rms}^{2} \cdot R_{L})}{A} = \frac{(0.0193 + 0.0165)mA^{2} \cdot 500\Omega}{4cm \cdot 4cm} = 1.12 \ mW/cm^{2}$$ {6}------------------------------------------------ ### E. 510(k) Summary (per 21 CFR 807.92) #### 7 Non-clinical Testing: FD2070 is compliànce 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: FD2070 has the same intended use and the same technical characteristics as the predicate device FD TENS 2030 (K052813). FD2070 is as safe and as effective as the predicate device. {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 MAR - 1 2012 Fuji Dynamics Ltd c/o Mr. Tim Ng Product Development Manager Unit 1-3, 23/F., Laws Commercial Plaza 788 Cheung Sha Wan Road Hong Kong, China Re: K111654 Trade/Device Name: FD TENS 2070 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: February 8, 2012 Received: February 23, 2012 Dear Mr. Ng: 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. {8}------------------------------------------------ Page 2 - Mr. Tim Ng 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Kesia Alexander 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 {9}------------------------------------------------ ### Indication For Use D. 510(k) Number (if known) : K111654 Model No.: FD2070 Device Name: Mini TENS FD TENS 2070 ## Indications For Use: FD2070 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the pain and/or as an adjunctive treatment in the management of chronic intractable post-traumatic acute pain. post-traumatic acute pain. Prescription Use X 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) PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daryl L. Kaufman M.A. (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number K111654 D-1/1

FD TENS 2070

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Device Story

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