(126 days)
Not Found
No
The device description and intended use focus on standard electrical stimulation for pain relief and muscle treatment, with no mention of AI or ML technologies. The performance studies listed are for electrical safety and EMC, not AI/ML performance metrics.
Yes.
The device is intended for medical purposes such as managing chronic pain, treating post-surgical and post-traumatic acute pain, preventing muscle disuse atrophy, relaxing muscle spasms, and increasing local blood circulation, all of which are therapeutic applications.
No
The provided text explicitly states the intended uses of the device (symptomatic relief of pain, muscle re-education, etc.) and describes how it functions (generating electrical pulses to stimulate nerves or muscles). It does not mention any diagnostic capabilities such as measuring or interpreting physiological data to identify a medical condition.
No
The device description explicitly states that the device "generates electrical pulses and transmit it to the electrodes which are attached to the patient's skin," indicating the presence of hardware components responsible for generating and delivering electrical stimulation. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the FD TENS 2090 and FD TENS 2095 are TENS and EMS devices. These devices work by applying electrical stimulation to the body through electrodes placed on the skin. They are used for pain relief, muscle stimulation, and related therapeutic purposes.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is entirely external and involves delivering electrical pulses to the body.
Therefore, the intended use and device description align with a therapeutic electrical stimulation device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
As a TENS device, FD TENS 2090 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.
As a EMS device, FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:
- Prevention or retardation of muscle disuse atrophy.
- · Relaxation of muscle spasm.
- · Muscle re-education.
- · Maintaining or increasing range of motion.
- · Increasing local blood circulation.
- · Immediate post-surgical of calf muscle to prevent venous thrombosis.
FD TENS 2095 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.
Product codes
GZJ, IPF
Device Description
FD TENS 2090
FD TENS 2090 can provide both TENS treatments and EMS treatments. During TENS treatments, the FD TENS 2090 generates 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 underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
During EMS treatments, FD TENS 2090 generates electrical pulses and transmit it to the electrodes attached to the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms. prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, reeducate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
FD TENS 2095
FD TENS 2095 can provide TENS treatment, During treatment, the FD TENS 2095 generates 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.
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: IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) Safety requirement, IEC 60601-1-2:2007 (Edition 3) EMC requirement. 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
Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to create a sense of depth and connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2016
Fuji Dynamics Ltd. Man Man Chung Product Development Manager 1-3. 23/F.. Laws Commerical Plaza 788 Cheung Sha Wan Road Hong Kong, China
Re: K152676
Trade/Device Name: FD TENS 2090 and FD TENS 2095 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: December 16, 2015 Received: December 21, 2015
Dear Man Man Chung:
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152676
Device Name FD TENS 2090 and FD TENS 2095
Indications for Use (Describe)
As a TENS device, FD TENS 2090 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.
As a EMS device. FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:
- Prevention or retardation of muscle disuse atrophy.
- · Relaxation of muscle spasm.
- · Muscle re-education.
- · Maintaining or increasing range of motion.
- · Increasing local blood circulation.
- · Immediate post-surgical of calf muscle to prevent venous thrombosis.
FD TENS 2095 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary [As required by 21 CFR 807.92]
Device 510(k) number: K152676
1. Applicant Information
| Date prepared: | Aug 3, 2015 | |
|---|---|---|
| Submitter: | Fuji Dynamics Ltd. | |
| Unit 1-3, 23/F., Laws Commercial Plaza | ||
| 788 Cheung Sha Wan Road, Kowloon | ||
| Hong Kong | ||
| Contact Person: | Man Man Chung | |
| Tel: | (852) 2786 4218 | |
| Fax: | (852) 2744 6775 |
2. General Device Information/Trade name
| Model No: | FD TENS 2090
FD TENS 2095 |
|--------------|------------------------------|
| Common Name: | Transcutaneous Elec |
trical Nerve Stimulator and Powered Muscle Stimulator GZJ, IPF Product code: Classification: Class II
3. Predicate Device Information
| 510k number | Device Name | Manufacturer | Date cleared |
|---|---|---|---|
| K052813 | FD TENS 2030 | Fuji Dynamics | 2006 |
| K063642 | FD EMS | Fuji Dynamics | 2007 |
4. Device Description
FD TENS 2090
FD TENS 2090 can provide both TENS treatments and EMS treatments. During TENS treatments, the FD TENS 2090 generates 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 underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.
During EMS treatments, FD TENS 2090 generates electrical pulses and transmit it to the electrodes attached to the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms. prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, reeducate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.
FD TENS 2095
FD TENS 2095 can provide TENS treatment, During treatment, the FD TENS 2095 generates 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.
4
5. Intended Use:
FD TENS 2090
As a TENS device, FD TENS 2090 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.
As a EMS device, FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:
- · Prevention or retardation of muscle disuse atrophy.
- Relaxation of muscle spasm.
- · Muscle re-education.
- · Maintaining or increasing range of motion.
- · Increasing local blood circulation.
- · Immediate post-surgical of calf muscle to prevent venous thrombosis.
FD TENS 2095
FD TENS 2095 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.
6. Comparison to Predicate Device:
TENS Program comparison between FD TENS 2090, FD TENS 2095 and FD TENS 2030
| Characteristic | Subject device K152676 | Predicate device K052813 |
|---|---|---|
| Device | FD TENS 2090 and FD TENS 2095 | FD TENS 2030 |
| Waveform | Symmetrical Bi-Phasic | Symmetrical Bi-Phasic |
| Shape | Rectangular | Rectangular |
| Maximum Voltage | ||
| Load: 0.50 kohm | (0-peak voltage) | |
| 48.8V | (0-peak voltage) | |
| 31.3V | ||
| 02 kohm | 70.4V | 50.7V |
| 10 kohm | 88.8V | 85.0V |
| Maximum Current | ||
| Load: 0.50 kohm | 97.6 mA | 62.6 mA |
| 02 kohm | 35.2 mA | 25.35 mA |
| 10 kohm | 8.88 mA | 8.5 mA |
| Maximum pulse width | 250μs | 250μs |
| Maximum frequency | 150 Hz | 200 Hz |
| Maximum Output | ||
| Net charge per phase | ||
| Load: 500 ohm | 10.41 μC | 5.83μC |
| Maximum output | ||
| Charge per phase | ||
| Load: 500 ohm | 22.13μC | 15.77μC |
| 1kohm | 16.33μC | 13.60μC |
| Maximum output | ||
| RMS Current | ||
| Load: 500 ohm | 11.55 mA rms | 10.99 mA rms |
| 1kohm | 8.49 mA rms | 8.95 mA rms |
| Max Current Density | 0.15 | 0.1 |
5
| (mA/cm²) | Max Power Density (W/cm²) | |
|---|---|---|
| .00525 | .00182 | |
| Burst Mode | Burst 1 | Burst II |
| a. Pulses per burst | 7 | 7 |
| b. Burst per second | 2 bursts per second | 2 |
| c. Burst duration | 250 ms | 250ms |
| d. Duty cycle | 50% | 50% |
| Burst 2 | Burst I | |
| a. Pulses per burst | 80 | 80 |
| b. Burst per second | 1 burst per 2 seconds | 1 burst per 2 seconds |
| c. Burst duration | 1 second | 1 second |
| d. Duty cycle | 50% | 50% |
| Continuous Mode | P1 CONST | CONSTANT |
| a. Pulse width | 59µs default | 50µs default |
| Adjustable from 50µs to | ||
| 250µs | Adjustable from 25 to 250µs | |
| b. Pulse frequency | 120 Hz default | 120 Hz default |
| Adjustable from 1 to 150 Hz | Adjustable from 1 to 200 Hz | |
| Pulse width modulation | P4 MODUL 1 | W. MODUL |
| a. Pulse width | 50µs to 250µs in 5s | 25µs to 250µs in 8s |
| b. Pulse frequency | 120Hz default | 120 Hz default |
| Adjustable from 1 to 150 Hz | Adjustable from 1 to 200 Hz | |
| Frequency modulation | P5 MODUL 2 | F. MODUL |
| a. Pulse frequency | 20 to 100 Hz in 5s | 20 to 100Hz in 8s |
| b. Pulse width | 150µs default | 50µs default |
| Adjustable from 50 to 250µs | Adjustable from 25 to 250µs |
EMS Program comparison between FD TENS 2090 and FD EMS
| Characteristic | Subject device K152676 | Predicate device K063642 |
|---|---|---|
| Trade name | FD TENS 2090 | FD EMS |
| Waveform | Symmetrical Bi-Phasic | Symmetrical Bi-Phasic |
| Shape | Rectangular | Rectangular |
| Maximum Voltage | (0 to peak voltage) | (0 to peak voltage) |
| Load: 500 ohm | 48.4 V | 48.7 V |
| 2 kohm | 67.2 V | 60.0 V |
| 10 kohm | 87.2 V | 64.7 V |
| Max Output current | ||
| Load: 500 ohm | 96.8 mA | 97.40 mA |
6
| 2 kohm | 33.6 mA | 30.0 mA |
|---|---|---|
| 10 kohm | 8.72 mA | 6.47 mA |
| Max pulse width | 300μs | 300μs |
| Max frequency | 40 Hz | 60 Hz |
| Biphasic waveform | Symmetrical Bi-Phasic | |
| Rectangular Waveform | Symmetrical Bi-Phasic | |
| Rectangular Waveform | ||
| - Symmetrical phases |
- Phase Duration | Fixed Pulse width, max 300 μs | Fixed Pulse width, max 300 μs |
| Maximum Output Net
Charge Per Phase
Load: 500 ohm | 13.05μC | 3.57 μC |
| Maximum Output Charge
Per Phase
Load: 500 ohm
1 kohm | 24.11 μC
17.77 μC | 48.61 μC
28.77 μC |
| Maximum Output RMS
Current
Load: 500 ohm
1 kohm | 6.62 mA rms
4.91 mA rms | 12.5 mA rms
7.40 mA rms |
| Max Current Density
(mA/cm2) | 0.046 | 0.1966 |
| Max Power Density (W/cm2) | 0.00152 | 0.00614 |
| On Time | 5 or 10 sec fixed | 1 to 9 sec adjustable |
| Off Time | 10 or 30 sec fixed | 1 to 9 sec adjustable |
| Output pattern -
EMS Cycle Mode | Fixed pulse frequency, ramp
up/down and work/rest time.
Only pulse width is user
selectable.
(P6,P8,P9) | Fixed pulse widthandwork/rest time.
Selectable frequency and ramp
up/down time. |
| EMS Reciprocal Mode | Fixed pulse frequency, ramp
up/down and work/rest time.
Only pulse width is user
selectable
(P7). | Fixed pulse width andwork/rest time.
Selectable pulse frequency and ramp
up/down time. |
| Preset Program,P6 of subject
device | Program Name
P6
EMS Mode
Cycle mode
Pules Freq: 35Hz
Pulse width:300μs
Ramp up : 2sec
On time : 10sec
Ramp down : 2sec
Off time : 30sec | Program Name
CYCLE 2
EMS Mode
Cycle mode
Pules Freq: 50Hz*
Pulse width:300μs
Ramp up : 3sec
On time : 9sec
Ramp down : 3sec
Off time : 15sec |
| Preset Program,P7of subject
device | Program Name
P7
EMS Mode
Reciprocal mode
Pules Freq: 40Hz
Pulse width:300μs | Program Name
RECIPROCAL 3
EMS Mode
Reciprocalmode
Pules Freq: 50Hz*
Pulse width:300μs |
7
| Ramp up : 4sec | Ramp up : 4sec | |
|---|---|---|
| On time : 10sec | On time : 8sec | |
| Ramp down : 4sec | Ramp down :4sec | |
| Off time : 10sec | Off time : 14sec | |
| Preset Program, P8 | Program Name | Program Name |
| P8 | CYCLE 2 | |
| EMS Mode | EMS Mode | |
| Cyclemode | Cycle mode | |
| Pules Freq: 40Hz | Pules Freq: 50Hz* | |
| Pulse width:300μs | Pulse width:300μs | |
| Ramp up : 4sec | Ramp up : 3sec | |
| On time : 10sec | On time : 9sec | |
| Ramp down : 4sec | Ramp down : 3sec | |
| Off time : 10sec | Off time : 15sec | |
| Preset program P9 | Program Name | Program Name |
| P9 | CYCLE 1 | |
| EMS Mode | EMS Mode | |
| Cyclemode | Cycle mode | |
| Pules Freq: 20Hz | Pules Freq: 50Hz* | |
| Pulse width:200μs | Pulse width:300μs | |
| Ramp up : 2sec | Ramp up : 2sec | |
| On time : 5sec | On time : 6sec | |
| Ramp down : 2sec | Ramp down : 2sec | |
| Off time : 10sec | Off time : 10sec | |
| Preset Program, P1 | Program Name | Program Name |
| P1 | CONSTANT 1 | |
| Pulse width: | Pulse width: | |
| 120µs default | 50 µs fixed | |
| Adjustable from | Pulse freq: | |
| 50µs to 250µs | 30Hz fixed | |
| Pulse freq: | -------------------- | |
| 120Hz default | Program Name | |
| adjustable from 1 to 150Hz | CONSTANT 2 | |
| Pulse width | ||
| 200µs fixed | ||
| Pulse freq: | ||
| 50Hz |
7. Non clinical Testing
IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1-2:2007 (Edition 3)
Safety requirement EMC requirement
8. Clinical testing
None
9. Conclusion
FD TENS 2090 and FD TENS 2095 have the same intended use and the same technical characteristics as the predicate device(s), FD TENS 2030 (K052813) and FD EMS (K063642). FD TENS 2090, FD TENS 2095 are as safe and as effective as the predicate device. Therefore, FD TENS 2090 and FD TENS 2095 are substantially equivalent to the predicate device.