(149 days)
Not Found
No
The description details a standard TENS device with preset programs and manual intensity adjustment, with no mention of AI or ML capabilities.
Yes
The device is used for "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," which describes a therapeutic purpose.
No
The device description indicates it is a TENS device used for symptomatic relief of pain by blocking pain signals, not for diagnosing conditions.
No
The device description explicitly states it is a "handheld battery powered TENS device" that generates electrical pulses and transmits them via electrodes, indicating it is a hardware device with electrical components.
Based on the provided information, the FD2050 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain by applying electrical pulses to the patient's skin. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a TENS (Transcutaneous Electrical Nerve Stimulation) device that generates electrical pulses and transmits them to electrodes on the skin. This mechanism of action is for pain relief, not for analyzing samples from the human body.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The FD2050 does not interact with such specimens.
Therefore, the FD2050 is a therapeutic medical device, specifically a TENS device, and not an IVD.
N/A
Intended Use / Indications for 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.
Product codes
GZJ
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.
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..
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Clinical Testing: None
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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.
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.
1
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 TENS
K111645 | SMART TENS
K091045 (Predicate Device) |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Waveform | Asymmetrical Bi-Phasic
Rectangular Waveform | Asymmetrical Bi-Phasic
Rectangular Waveform |
| Maximum Voltage
(0 to peak voltage) | 60V @500Ω
75V @2kΩ
83V @10kΩ | 61V @500Ω
76V @2kΩ
90V @10kΩ |
| Max Output Current | 120 mA @500Ω
37 mA @2kΩ
8 mA @10kΩ | 122 mA @500Ω
38 mA @2kΩ
9 mA @10kΩ |
| Maximum Pulse Width | 250 μs | 250 μs |
| Maximum Frequency | 150Hz | 100Hz |
| Maximum Output
Charge Per Phase | * 23.0μC @500Ω
17.1μC @1kΩ
11.9μC @2kΩ
3.4μC @10kΩ | 28.4μC @500Ω
21.3μC @1kΩ
13.9μC @2kΩ
3.9μC @10kΩ |
| Maximum Output
Net Charge Per Phase | * 11.9μC @500Ω
6.2μC @1kΩ
2.9μC @2kΩ
0.4μC @10kΩ | 14.4μC @500Ω
6.5μC @1kΩ
2.9μC @2kΩ
0.4μC @10kΩ |
| Maximum Output
RMS Current | * 13.1 mArms @500Ω
8.4 mArms @1kΩ
5.3 mArms @2kΩ
1.4 mArms @10kΩ | 14.4 mArms @500Ω
10.0 mArms @1kΩ
6.3 mArms @2kΩ
1.7 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 timer
Continuous 15 minutes
30 minutes 45 minutes
60 minutes | 5 selectable timer
Continuous 15 minutes
30 minutes 45 minutes
60 minutes |
| Continuous Stimulation
(CONTS) | 150µs
Selectable 1Hz to 150Hz | 100Hz
Selectable 20µs to 250µs |
| Burst
(BURST 1
BURST 2) | Burst 1
28Hz, 150µs, 2 bursts/sec, 7
pulses/burst
Burst 2
80Hz, 150µs, 1 burst/2sec, 80
pulses/burst | 32Hz, selectable 20µs to 250µs
2 burst/sec, 7 pulses/burst |
| Pulse Width Modulation
(MODUL 1) | 50µs -> 250µs in 6sec
250µs -> 50µs in 6sec
repeat | 20µs -> max pulse width in 5 sec
max pulse width ->20µs in 5sec
repeat |
| | 42 selectable pulse rate
between 1Hz and 150Hz | 23 selectable max pulse width
between 20µs and 250µs |
| Frequency Modulation
(MODUL 2) | Pulse width 150µs
20Hz -> 100Hz in 6sec
100Hz -> 20Hz in 6sec
Then repeat | Not Available |
4
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.
$$I_{rms}^2 = \frac{1}{T} \int_{t_i}^{t_f} \left(\frac{\mathbf{V}_1}{R_L} \mathbf{e}^{-\left(\mathbf{t} - \mathbf{t}_i\right)/\tau}\right)^2 dt = \frac{\tau}{2T} \left(\frac{\mathbf{V}_1}{R_L}\right)^2 \left(\mathbf{l} \cdot \mathbf{e}^{-\epsilon_s/\tau}\right)$$
$$I_{rms}^{2} = \frac{208\mu s}{2(1/150Hz)} \left(\frac{60V}{500\Omega}\right)^{2} (1 - e^{-250\mu s / 208\mu s}) = 0.157 lmA^{2}$$
$$+ve Pulse I_{rms}^{2} = 0.1571mA^{2}$$
$$-ve Pulse I_{rms}^{2} = 0.0132mA^{2}$$
$$I_{rms} = \sqrt{0.1571mA^{2} + 0.0132mA^{2}} = 13.1mA$$
$$MaxPowerDensity = \frac{Effective Power}{Area of Electrode} = \frac{\sum (I_{rms}^{2} \cdot R_{L})}{A}$$
$$= \frac{(0.1571 + 0.0132)mA^{2} \cdot 500\Omega}{4cm \cdot 4cm} = 5.3 mW/cm^{2}$$
5
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.
6
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.
7
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
8
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