(161 days)
No
The description focuses on preset and user-programmable stimulation parameters, with no mention of adaptive algorithms, learning from patient data, or other characteristics typically associated with AI/ML. The "masking program" and "locking the device" features are described as simple control mechanisms, not intelligent systems.
Yes
The device is a TENS/NMES stimulator indicated for symptomatic relief and management of chronic pain, post-surgical pain, and for various muscle and circulation-related therapeutic uses.
No
This device is a TENS/NMES stimulator used for pain relief and muscle stimulation, which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it is a "2 channel TENS/NMES stimulator device" and lists physical components such as the "TENS/NMES unit powered by DC 3.7-volt lithium battery", "wires for electrodes", "self adhesive electrodes", and a "battery rechargeable unit". This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for symptomatic relief and management of pain, muscle spasms, disuse atrophy, blood circulation, muscle re-education, prevention of venous thrombosis, and maintaining range of motion. These are all therapeutic applications, not diagnostic ones.
- Device Description: The description details a TENS/NMES stimulator that delivers electrical pulses to the body. This is a physical therapy device, not a device that analyzes samples from the body (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
In summary, the OGYILI TENS/NMES Stimulator E01 is a therapeutic medical device used for pain management and muscle stimulation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TENS function of the device is indicated for the following use:
Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain
NMES function of the device is indicated for the following use:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Product codes (comma separated list FDA assigned to the subject device)
GZJ, IPF
Device Description
The OGYILI TENS/NMES Stimulator E01 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The OGYILI TENS/NMES Stimulator is a programmable device that come equipped with 14 preset programs along with 14 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The OGYILI TENS/NMES Stimulator is programmed to default to program P- 14 which contains the most common setting.
The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs.
The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery.
OGYILI TENS/NMES Stimulator package is comprised of the following items:
- One TENS/NMES unit powered by DC 3.7-volt lithium battery
- Two UL industry standard wires for electrodes conforming to FDA standards
- Four standard commercially available round 100 (mm) self adhesive electrodes.
- One UL 110 battery rechargeable unit
- Instruction manual.
- Quick start instruction manual.
- . Full package carrying case.
The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.
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
18 years and older
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)
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the device does not raise any new questions of safety and effectiveness.
The subject device conforms to the following standards:
- IEC 60601-2-10, Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-6, General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability
- IEC60601-1, Electrical safety;
- IEC60601-1-2, Electromagnetic compatibility
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
The output performances of the subject device are either within the range covered by the predicate device, or in the close proximity of the range covered by the predicate device. The subject device essentially has the same performance as that of the predicate device. Our device is essentially identical to the predicate device in terms of indications for use, design, and mechanism, between subject device and the predicate device.
Tests were conducted following applicable procedures outlined in the internal procedures and FDA recognized consensus standards, and results met all relevant requirements in the test standards, and are comparable to the predicate device in performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2020
Gongguan Tutamen Metalwork Co., LTD % Charles Shen Official Correspondent Manton Business and Technology Services 37 Winding Ridge Oakland, New Jersey 07436
Re: K201431
Trade/Device Name: OGYILI TENS/NMES Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ, IPF Dated: August 11, 2020 Received: August 13, 2020
Dear Charles Shen:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmr/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K201431
Device Name
OGYILI TENS/NMES Stimulator
Indications for Use (Describe)
TENS function of the device is indicated for the following use:
Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain
NMES function of the device is indicated for the following use:
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- · Muscle re-education
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Maintaining or increasing range of motion
| 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:
This summary of 510k safety and effectiveness information is being submitted In accordance with the requirements of 21CFR 807.92
5.1 Submitter & Foreign Manufacture Identification
Dongguan Tutamen Metalwork Co., LTD.
No.2, HuangGuoTang Rd, Shahu, Tangxia Town Dongguan, Guangdong Province, 523001 CHINA Tel: (086) 769 87989845 Submitter's FDA Registration Number: N/A
5.2 Contact Person
Charles Shen Manton Business and Technology Services 37 Winding Rdg, Oakland, NJ 07436 Tel: 608-217-9358 Email: cyshen@aol.com
5.3 Date of Summary: November 02, 2020
5.4 Device Name:
| Proprietary Name: | OGYILI TENS/NMES Stimulator |
|---|---|
| Device Common Name: | TENS/NMES Stimulator |
| Classification Regulation: | 21 CFR882.5890 |
| Class: | Class 2 |
| Panel: | Neurology |
| Product Code: | GZJ |
| Subsequent Product Code: | IPF |
| Prior FDA correspondence: | None |
ર્સ્ટ Predicate Device Information:
The "OGYILI TENS/NMES Stimulator E01" described in this premarket notification is substantially equivalent to:
-
K193275. "Nerve and Muscle Stimulator (model: XFT-2000)", Manufactured by (1) "Shenzhen XFT Medical Limited"
Reference Device: -
(2) K092990, "AMD 6605" manufactured by "Shenzhen Dongdixin Technology Co., Ltd.''
4
- K162517, "Electronic Pulse Stimulator", Manufactured by "JKH Health Co., (3) Ltd."
Device Description: ર્સ્વ
The OGYILI TENS/NMES Stimulator E01 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The OGYILI TENS/NMES Stimulator is a programmable device that come equipped with 14 preset programs along with 14 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The OGYILI TENS/NMES Stimulator is programmed to default to program P- 14 which contains the most common setting.
The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs.
The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery.
OGYILI TENS/NMES Stimulator package is comprised of the following items:
- One TENS/NMES unit powered by DC 3.7-volt lithium battery ●
- Two UL industry standard wires for electrodes conforming to FDA standards, ●
- Four standard commercially available round 100 (mm) self adhesive electrodes.
- One UL 110 battery rechargeable unit
- Instruction manual. ●
- Quick start instruction manual. ●
- . Full package carrying case.
The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.
5
5.7 Indications for Use:
TENS function of the device is indicated for the following use:
Symptomatic relief and management of chronic (long-term). intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain
NMES function of the device is indicated for the following use:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy ●
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis ●
- Maintaining or increasing range of motion ●
5.8 Performance Testing Summary:
Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the device does not raise any new questions of safety and effectiveness.
The subject device conforms to the following standards:
- IEC 60601-2-10, Particular requirements for the basic safety and essential ● performance of nerve and muscle stimulators
- IEC 60601-1-6, General Requirements For Basic Safety And Essential ● Performance - Collateral Standard: Usability
- IEC60601-1, Electrical safety; ●
- IEC60601-1-2, Electromagnetic compatibility ●
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and ● testing within a risk management process
Technological Comparison with Predicate Device 5.9
Table 5.1 below shows similarities and differences of use, mechanism, and labeling between our device and the predicate devices.
6
Table 5.1: Comparison of Intended Use, Mechanism, and Labeling
| Description | Subject Device | Primary Predicate Device
(K193275) | Reference Device (K092990) | Remark | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------|
| Product Code | GZJ | GZJ | GZJ | SE | |
| Regulation
Number | 21 CFR882.5890 | 21 CFR882.5890 | 21 CFR882.5890 | SE | |
| Indication For
Use | TENS function of the device is
indicated for the following use:
Symptomatic relief and
management of chronic (long-
term), intractable pain and an
adjunctive treatment in the
management of post-surgical
pain and post-traumatic acute
pain
NMES function of the device is
indicated for the following use:
Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion | Over-The-Counter Use:
TENS[ (Program 1~9,
Program 15 (Frequency15Hz)]: XFT-2000 is
used for temporary relief of
pain associated with sore and
aching muscles due to strain
from exercise or normal
household and work activities.
XFT-2000 is also intended for
the symptomatic relief and
management of chronic,
intractable pain and relief of
pain associated with arthritis.
NMES[ (Program 10~14,
Program
15(5Hz≤Frequency≤50Hz)]:
XFT-2000 is used to stimulate
healthy muscles in order to
improve and facilitate muscle
performance. To be used for
the improvement of muscle
tone and firmness, and for
strengthening muscles in the
arms, abdomen, legs, and
buttocks. Not intended for use
in any therapy or for the
treatment of any medical
conditions or diseases.
Prescription Use:
XFT-2000 is intended for the
following use:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion | TENS function of the device is
indicated for the following
use:
Symptomatic relief and
management of chronic (long-
term), intractable pain and an
adjunctive treatment in the
management of post-surgical
pain and post-traumatic acute
pain
NMES function of the device
is indicated for the following
use:
Relaxation of muscle spasms Prevention or retardation of disuse atrophy Increasing local blood circulation Muscle re-education Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis Maintaining or increasing range of motion | SE | |
| | | - Adjunctive treatment in the
management of post-surgical
and post-traumatic acute pain | | | |
| Target
Population | 18 years and older | Adult Population | 18 years and older | SE | |
| Components | Control unit and electrode | Control unit and electrode | Control unit and electrode | SE | |
| Contradictions | Never use your TENS/NMES
on:
Atrophied muscles.
Muscles with spasms.
Muscles associated with an
impaired joint or limb.
Muscles with undiagnosed pain.
Never use the TENS/NMES
when pregnant or if you think
you are pregnant.
Do not use your TENS/NMES
With cardiac pacemakers,
defibrillators, or other implanted
metallic or electronic devices.
Over or around the neck/carotid
sinus.
Over the neck, mouth or face.
Over the carotid sinus nerves.
Trans cerebrally (over the head).
Over/around the eyes.
Over the heart or chest.
When there is a possibility to
haemorrhage following acute
trauma or fracture.
After surgical procedures when
muscle contraction may affect the
healing process.
On areas of skin which lack
normal sensation | Not available as public
information | Patients with pacemakers and
heart conditions Patients with
pacemakers and heart
conditions TENS/NMES:
should NOT use - should NOT
use Do NOT use stimulation
over the carotids Do NOT use
stimulation over the carotids
sinus nerves, the larynx or
throat muscles sinus nerves,
the larynx or throat muscles
Do NOT use stimulation trans-
cerebrally. Do NOT use
stimulation trans-cerebrally.
Do NOT use on undiagnosed
pain or until Do NOT use on
undiagnosed pain or until I
etiology is established. | Similar | |
| Characteristic | Subject device (K201431) | Primary Predictive Device (K193275) | Reference Device (K092990) | Reference Device (K162517) | Remarks |
| Unit Name: | OGYILI TENS/NMES UNIT | XFT - 2000 | AMD 6605 | PL-029K12 | |
| Manufacturer | Tutamen Metal Co., LTD | Shenzhen XFT Medical Limited | Shenzhen Dongdixin Technology Co., Ltd. | JKH USA LLC | |
| Power source | Use a Lithium-ion battery | DC4.5V, 3xAAA batteries; DC adaptor | Battery | Rechargeable or non-rechargeable battery | SE |
| a. Method of Line Current isolation | N/A battery operated | N/A battery operated | N/A battery operated | N/A battery Operated | SE |
| b. Patient Leakage current | N/A battery operated | N/A battery operated | N/A battery operated | N/A battery operated | SE |
| a. Normal condition | N/A battery operated | N/A battery operated | N/A battery operated | N/A battery operated | SE |
| b. Single Fault Condition | N/A battery operated | N/A battery operated | N/A battery operated | N/A battery operated | SE |
| Average DC current through electrodes when device is on but no pulses are being applied | User pure AC, No DC current used | User pure AC, No DC current used | User pure AC, No DC current used | User pure AC, No DC current used | SE |
| Number of output modes | 14 programs | 15 programs | Information not available | 8 programs | Similar |
| Output channels | 2 output Channels | 2 output channels | 2 output channels | 1 output channel | SE |
| a. Method of current isolation | Individually isolated circuits, and transistors | Individually isolated circuits, and transistors | Individually isolated circuits, and transistors | NA | SE |
| Regulated Current or Regulated Voltage? | Regulated Voltage | Regulated Current | Information not available | Regulated voltage | SE |
7
The subject device are predicate devices are essentially identical in terms of use, and mechanism. They have minor different wording in the descriptions of contradictions, but the actual contents are very similar.
8
Table 5.2 shows similarities and differences of mechanism and design between our device and the predicate devices.
Table 5.2: Comparison of Mechanism and Design
9
| Indicator Display: | Shows On/Off Status | Shows On/Off Status | SE | ||
|---|---|---|---|---|---|
| On/OFF Status? | Yes, Shows On/off status | Shows On/Off Status | Yes shows battery low | ||
| Low Battery? | Yes, Shows Low Battery | Yes shows battery low | Shows voltage level | ||
| Voltage/Current Level? | Yes, shows output level 1-15 | ||||
| (1 being low 15 being high) | Shows voltage level | ||||
| Software | |||||
| firmware, microprocessor | |||||
| control | MCU: PIC16F1937 Edition | ||||
| V1.0 | MCU | MCU | MCU | SE | |
| Automatic overload trip | Yes | Yes | NO, Battery operated | NO | |
| Automatic No load trip | Yes | Yes | NO, Battery Operated | Yes | |
| Automatic Shut Off | Yes | Yes | Yes | Yes | |
| User Override control | Yes, pause button | Yes, pause button | Yes (anytime) | Yes, pause button | |
| Timer Range (minutes) | 15min - 60min | 60min | 15min - 60min | 10- 540min | |
| Hardware and materials | |||||
| Housing construction | |||||
| material | ABS | ABS | ABS | ABS | SE |
| Size: | 92 x 60 x 18mm | 108 x 62 x 26mm | 141 (L) x 60(W) X | ||
| 18(H) mm | n/a | ||||
| Weight: | 0.07 kg. without battery, | ||||
| 0.09kg. with battery | 96g with battery | 115 grams | 25g | ||
| Electrode Lead wires | |||||
| Length | 1.m | 2' round self-adhering | SE | ||
| Construction | Strand | reusable Amgel based | |||
| Materials | Copper wire PVC Coating | electrodes, FDA | |||
| Electrode connectors | 2x2mm Pin connector | approved | |||
| 510K number: | K171722 | K132588 |
The subject device is essentially identical to the predicate device in terms mechanism and design. The differences in number of programs, dimension and weight does not raise safety and effectiveness issues. The electrode leas wire is FDA 510(K) cleared, as the predicate devices.
10
Table 5.3 shows similarities and differences of output performance between our device and the predicate devices.
| Characteristic | Subject device (K201431) | Primary Predictive Device
(K193275) | Reference Device (K162517) | Remarks |
|--------------------------------------------------|------------------------------|----------------------------------------|--------------------------------|---------|
| Shape | Rectangular | Rectangular | Rectangular | SE |
| Maximum Output
Voltage (V) (+/-%) | 17-20v +/-20%@ 500kΩ | 29.7-39v +/-20%@ 500kΩ | 29.6-57.6v +/-20%@ 500kΩ | SE |
| | 48-60v +/-20%@ 2KΩ | 89.1-90.6v +/-20%@ 2KΩ | 80.8-86.4v +/-20%@ 2KΩ | |
| | 95-125v +/-20%@ 10KΩ | 123-125v +/-20%@ 10KΩ | 108-134v +/-20%@ 10KΩ | |
| Maximum Output
Current (mA) (+/-%) | 36-40mA +/-20%@ 500Ω | 59-60mA +/-20%@ 500Ω | 59.2-115.2mA +/-20%@ 500Ω | SE |
| | 24-30mA +/-20%@ 2KΩ | 44-45.3mA+/-20% @ 2KΩ | 33.2-48mA+/-20% @ 2KΩ | |
| | 9-12.5mA +/-20%@ 10KΩ | 12.3-12.5mA +/-20%@ 10KΩ | 10.8-13.4mA +/-20%@ 10KΩ | |
| Pulse duration† (us) | 100-200 μS @ 500Ω | 150-350 μS 500Ω | 100 μS | SE |
| Frequency (Hz) {or Rate
(pps)} | 2-150 Hz | 2-125 Hz | 1.9-104.1 Hz | SE |
| Net Charge
(microcoulombs (μC) per
pulse) | 12-21 [μC] @ 500Ω | 5.9-21 [μC] @ 500Ω | 11.8-23 [μC] @ 500Ω | SE |
| Maximum Phase Charge
(μC) | 12-21 [μC] @ 500Ω | 5.9-21 [μC] @ 500Ω | 11.8-23 [μC] @ 500Ω | SE |
| Maximum Current
density ††(mA/cm2,
r.m.s.) | 0.16-0.54mA/cm2@500Ω | 0.15-0.72mA/cm2@500Ω | 1.64-3.26mA/cm2@500Ω | SE |
| Maximum Average
Power Density††
(W/cm2) | 0.0002-0.0026mA/cm2
@500Ω | 0.0002-0.0045mA/cm2
@500Ω | 0.00004-0.00101mA/cm2
@500Ω | SE |
| Burst Mode | Yes/No | Yes/No | n/a | |
| Pulses per Burst | 9 | 15-840 | n/a | SE |
| Bursts per Second | 2 | 0.07-0.33 | n/a | SE |
| Burst duration (seconds) | 175 μs – 5s | 3-14 | n/a | SE |
| ON Time (seconds) | 5-8 | 3-14 | 3.4-20 | SE |
| OFF time (seconds) | 5-12 | 2-10 | 1-2.5 | SE |
Table 5.3: Comparison of Output Performance
11
The output performances of the subject device are either within the range covered by the predicate device, or in the close proximity of the range covered by the predicate device. The subject device essentially has the same performance as that of the predicate device. Our device is essentially identical to the predicate device in terms of indications for use, design, and mechanism, between subject device and the predicate device.
The following table shows similarities and differences of the key performance between the subject device and the predicate devices. Tests were conducted following applicable procedures outlined in the internal procedures and FDA recognized consensus standards, and results met all relevant requirements in the test standards, and are comparable to the predicate device in performance.
| Description | Subject Device | Primary Predicate
Device (K193275) | Reference Device
(K092990) | Comparison |
|--------------------------|---------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------|------------|
| Biocompatibility | Biocompatible per ISO
10993-1 | Biocompatible per ISO
10993-1 | Biocompatible per ISO
10993-1 | SE |
| Electric Safety | The proposed device was
tested to demonstrate
compliance with IEC
60601-1 | Compliance with IEC
60601-1 | Compliance with IEC
60601-1 | SE |
| EMC | The proposed device was
tested to demonstrate
compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | Compliance with IEC
60601-1-2 | SE |
| Performance
Standards | The proposed device was
tested to demonstrate
compliance with IEC
60601-2-10 | Compliance with IEC
60601-2-10 | Compliance with IEC
60601-2-10 | SE |
Table 5.4: Comparison of Device Performance
The above table shows that the performance is either same or very similar between the subject and predicate device. The subject device is as safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.
5.10 Substantial Equivalence Conclusion
Based on the comparison of intended use. design, and performance, "OGYILI TENS/NMES" manufactured by "Dongguan Tutamen Metalwork Co., LTD." is substantial equivalent to its predicate devices.