(262 days)
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The description of the device as a standard TENS unit further supports this.
Yes
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) unit used for symptomatic relief and management of chronic intractable pain and as an adjunctive treatment for acute pain, which fits the definition of a therapeutic device.
No
The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) unit used for symptomatic relief and management of pain. Its function is to generate electrical pulses to block pain signals, not to identify or determine the nature of a medical condition.
No
The device description explicitly states it is a Transcutaneous Electrical Nerve Stimulator (TENS) unit that generates and transmits electrical pulses to electrodes attached to the skin, indicating it is a hardware device.
Based on the provided information, the FD2070 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a Transcutaneous Electrical Nerve Stimulator (TENS) unit. TENS devices work by applying electrical stimulation to the skin to block pain signals or stimulate endorphin release. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, the FD2070 is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
GZJ
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical Testing:
None
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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) :
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