OGYILI TENS/NMES Stimulator

K201431 · Gongguan Tutamen Metalwork Co., Ltd. · GZJ · Nov 9, 2020 · Neurology

Device Facts

• Record ID: K201431
• Device Name: OGYILI TENS/NMES Stimulator
• Applicant: Gongguan Tutamen Metalwork Co., Ltd.
• Product Code: GZJ · Neurology
• Decision Date: Nov 9, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

The OGYILI TENS/NMES Stimulator is a 2-channel, battery-powered (3.7V Li-ion) device used for pain management and muscle stimulation. It delivers bi-phase rectangular electrical pulses (2-150Hz, 100-200us) via self-adhesive electrodes. The device features 14 preset and 14 user-adjustable programs, with a clinician-controlled masking/locking function to prevent unauthorized patient modification of prescribed settings. It is intended for use by patients under clinician guidance. The device includes an automatic shut-off, overload/no-load trip, and pause functionality. Healthcare providers use the device to deliver specific stimulation regimens stored in memory slots to aid in pain relief, muscle rehabilitation, and circulation. Benefits include non-pharmacological pain management and physical therapy support.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through design control activities and testing against consensus standards: IEC 60601-2-10 (nerve/muscle stimulators), IEC 60601-1-6 (usability), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility). Results demonstrated that the device meets pre-defined acceptance criteria and is comparable to the predicate device.

Technological Characteristics

2-channel TENS/NMES stimulator; ABS housing (92x60x18mm, 90g); 3.7V Li-ion battery; bi-phase rectangular pulse (2-150Hz, 100-200us); regulated voltage output; copper wire/PVC electrodes with 2mm pin connectors. Connectivity: Standalone. Sterilization: Not applicable (non-sterile). Software: Microprocessor-controlled (PIC16F1937, V1.0). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-1.

Indications for Use

Indicated for adults (18+) for symptomatic relief of chronic intractable pain, adjunctive treatment of post-surgical/post-traumatic acute pain, relaxation of muscle spasms, prevention/retardation of disuse atrophy, increasing local blood circulation, muscle re-education, prevention of venous thrombosis via calf stimulation, and maintaining/increasing range of motion. Contraindicated for use with pacemakers/defibrillators, over carotid sinus/neck/mouth/face/eyes/heart/chest, trans-cerebrally, on atrophied/spastic muscles, on areas lacking sensation, during pregnancy, or for undiagnosed 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

• Nerve and Muscle Stimulator (model: XFT-2000) (K193275)

Reference Devices

• AMD 6605 (K092990)
• Electronic Pulse Stimulator (K162517)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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### 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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# 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: [phone] 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: [phone] Email: [e-mail]

#### 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.''

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- 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.

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#### 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.

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## Table 5.1: Comparison of Intended Use, Mechanism, and Labeling

| Description | Subject Device | Primary Predicate Device<br>(K193275) | Reference Device (K092990) | Remark | |
|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------|
| Product Code | GZJ | GZJ | GZJ | SE | |
| Regulation<br>Number | 21 CFR882.5890 | 21 CFR882.5890 | 21 CFR882.5890 | SE | |
| Indication For<br>Use | TENS function of the device is<br>indicated for the following use:<br>Symptomatic relief and<br>management of chronic (long-<br>term), intractable pain and an<br>adjunctive treatment in the<br>management of post-surgical<br>pain and post-traumatic acute<br>pain<br>NMES function of the device is<br>indicated for the following use:<br>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:<br>TENS[ (Program 1~9,<br>Program 15 (Frequency<5Hz<br>or >15Hz)]: XFT-2000 is<br>used for temporary relief of<br>pain associated with sore and<br>aching muscles due to strain<br>from exercise or normal<br>household and work activities.<br>XFT-2000 is also intended for<br>the symptomatic relief and<br>management of chronic,<br>intractable pain and relief of<br>pain associated with arthritis.<br><br>NMES[ (Program 10~14,<br>Program<br>15(5Hz≤Frequency≤50Hz)]:<br>XFT-2000 is used to stimulate<br>healthy muscles in order to<br>improve and facilitate muscle<br>performance. To be used for<br>the improvement of muscle<br>tone and firmness, and for<br>strengthening muscles in the<br>arms, abdomen, legs, and<br>buttocks. Not intended for use<br>in any therapy or for the<br>treatment of any medical<br>conditions or diseases.<br><br>Prescription Use:<br>XFT-2000 is intended for the<br>following use:<br>- Relaxation of muscle spasms<br>- Prevention or retardation of disuse atrophy<br>- Increasing local blood circulation<br>- Muscle re-education<br>- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis<br>- Maintaining or increasing range of motion | TENS function of the device is<br>indicated for the following<br>use:<br>Symptomatic relief and<br>management of chronic (long-<br>term), intractable pain and an<br>adjunctive treatment in the<br>management of post-surgical<br>pain and post-traumatic acute<br>pain<br>NMES function of the device<br>is indicated for the following<br>use:<br>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<br>management of post-surgical<br>and post-traumatic acute pain | | | |
| Target<br>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<br>on:<br>Atrophied muscles.<br>Muscles with spasms.<br>Muscles associated with an<br>impaired joint or limb.<br>Muscles with undiagnosed pain.<br><br>Never use the TENS/NMES<br>when pregnant or if you think<br>you are pregnant.<br><br>Do not use your TENS/NMES<br>With cardiac pacemakers,<br>defibrillators, or other implanted<br>metallic or electronic devices.<br>Over or around the neck/carotid<br>sinus.<br>Over the neck, mouth or face.<br>Over the carotid sinus nerves.<br>Trans cerebrally (over the head).<br>Over/around the eyes.<br>Over the heart or chest.<br>When there is a possibility to<br>haemorrhage following acute<br>trauma or fracture.<br>After surgical procedures when<br>muscle contraction may affect the<br>healing process.<br>On areas of skin which lack<br>normal sensation | Not available as public<br>information | Patients with pacemakers and<br>heart conditions Patients with<br>pacemakers and heart<br>conditions TENS/NMES:<br>should NOT use - should NOT<br>use Do NOT use stimulation<br>over the carotids Do NOT use<br>stimulation over the carotids<br>sinus nerves, the larynx or<br>throat muscles sinus nerves,<br>the larynx or throat muscles<br>Do NOT use stimulation trans-<br>cerebrally. Do NOT use<br>stimulation trans-cerebrally.<br>Do NOT use on undiagnosed<br>pain or until Do NOT use on<br>undiagnosed pain or until I<br>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 |

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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.

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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

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| 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<br>(1 being low 15 being high) | Shows voltage level | | | |
| Software | | | | | |
| firmware, microprocessor<br>control | MCU: PIC16F1937 Edition<br>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<br>material | ABS | ABS | ABS | ABS | SE |
| Size: | 92 x 60 x 18mm | 108 x 62 x 26mm | 141 (L) x 60(W) X<br>18(H) mm | n/a | |
| Weight: | 0.07 kg. without battery,<br>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.

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Table 5.3 shows similarities and differences of output performance between our device and the predicate devices.

| Characteristic | Subject device (K201431) | Primary Predictive Device<br>(K193275) | Reference Device (K162517) | Remarks |
|--------------------------------------------------|------------------------------|----------------------------------------|--------------------------------|---------|
| Shape | Rectangular | Rectangular | Rectangular | SE |
| Maximum Output<br>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<br>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-…