Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

K220998 · Shenzhen Kentro Medical Electronics Co., Ltd. · NUH · Aug 24, 2022 · Neurology

Device Facts

• Record ID: K220998
• Device Name: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
• Applicant: Shenzhen Kentro Medical Electronics Co., Ltd.
• Product Code: NUH · Neurology
• Decision Date: Aug 24, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended: for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping · to temporarily increase local blood circulation in healthy leg muscles · to stimulate healthy muscles in order to improve and facilitate muscle performance · to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties · to relax muscle spasm to increase blood flow circulation · for prevention of retardation of disuse atrophy for muscle re-education · for maintaining or increasing range of motion · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis · Provide quadricep strengthening · Improve knee stability secondary to quadricep strengthening 2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide: · symptomatic relief and management of chronic, intractable pain · relief of pain associated with arthritis · temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Device Story

Device (KTR-405) is a transcutaneous electrical nerve stimulator (TENS) and electrical muscle stimulator (EMS) for OTC use. Input: user-selected modes and intensity levels via wireless remote or device controls. Operation: device generates biphasic, pulsed symmetric, rectangular electric pulses delivered to skin via footpads or electrode patches. Used by patients in home/clinic settings while seated or reclining. Output: electrical stimulation to muscles/nerves. Clinical effect: temporary pain relief, increased local blood circulation, muscle conditioning, and prevention of disuse atrophy. Healthcare provider/patient uses output to manage chronic pain or post-surgical recovery. Benefits: non-invasive pain management, improved muscle performance, and reduced swelling.

Clinical Evidence

No clinical data. Bench testing only. Verification included software validation, waveform testing per FDA guidance, and biocompatibility testing (ISO 10993-5, ISO 10993-10) for footpads. Electrical safety and EMC testing performed per IEC 60601 series.

Technological Characteristics

Materials: ABS housing; footpads (silica gel); electrode patches (EVA foam, carbon film, hydrogel, PET). Energy: Mains or internal rechargeable battery. Output: 2 channels, 10 modes, 0-150 intensity levels. Waveform: Biphasic, pulsed symmetric, rectangular. Connectivity: Wireless remote control. Standards: IEC 60601-1, 60601-1-2, 60601-2-10, 60601-1-11, ISO 10993-5/10.

Indications for Use

Indicated for adults with conditions/diseases associated with impaired blood flow in legs/ankles/feet; adjunctive treatment to reduce lower extremity pain, swelling, cramping; increase local blood circulation; stimulate healthy muscles; improve muscle performance; relieve pain from sore/aching muscles (shoulder, waist, back, upper/lower extremities) due to strain; relax muscle spasms; prevent disuse atrophy; muscle re-education; maintain/increase range of motion; post-surgical calf stimulation to prevent venous thrombosis; quadricep strengthening; improve knee stability; symptomatic relief of chronic intractable pain; relief of arthritis 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

• Revitive Medic Coach (K210825)

Submission Summary (Full Text)

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August 24, 2022

Shenzhen Kentro Medical Electronics Co., Ltd. % Yvonne Liu Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90. Oianhai Road Shenzhen, Guangdong 518052 China

Re: K220998

Trade/Device Name: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX, IPF, NYN, GZJ Dated: July 12, 2022 Received: July 18, 2022

Dear Yvonne Liu:

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/cfpmn/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 Advice (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.

for Tushar Bansal, PhD Acting 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

Enclosure

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# Indications for Use

#### 510(k) Number (if known) K220998

#### Device Name

Transcutaneous Electrical Nerve Stimulator, Model: KTR-405

Indications for Use (Describe)

- 1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:
- for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance
- · to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities
- (arms) and lower extremities(legs) due to strain from exercise or normal household duties
- · to relax muscle spasm
- to increase blood flow circulation
- · for prevention of retardation of disuse atrophy
- for muscle re-education
- · for maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening

2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

- symptomatic relief and management of chronic, intractable pain
- · relief of pain associated with arthritis

· temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary K220998

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

# (1) Applicant information:

| 510(k) owner's name: | SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2nd Floor No 11, Shanzhuang Road, Xikeng Village, Yuanshan<br>Street, Longgang District, Shenzhen City, Guangdong<br>Province,China |
| Contact person: | Zewu Zhang |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Email: | [e-mail] |
| Date of summary prepared: | August 24, 2022 |

## (2) Reason for submission

New device, there were no prior submissions for the device.

## (3) Proprietary name of the device

| Trade name/model: | Transcutaneous Electrical Nerve Stimulator/ KTR-405 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common name: | Stimulator, Nerve, Transcutaneous, Over-The-Counter;<br>Stimulator, Muscle, Powered, For Muscle Conditioning;<br>Stimulator, Muscle, Powered;<br>Stimulator, Electrical, Transcutaneous, For Arthritis;<br>Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Regulation number: | 21 CFR 882.5890, 890.5850 |
| Product code: | NUH, NGX, IPF, NYN, GZJ |
| Review panel: | Neurology, Physical Medicine |
| Regulation class: | Class II |

## (4) Predicate device

| | Predicate device |
|-----------------------|---------------------------------------|
| Sponsor | ACTEGY LTD |
| Device Name and Model | Revitive Medic Coach<br>Model: 5575AQ |

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| 510(k) Number | K210825 |
|-------------------|---------------------------|
| Product Code | NGX, NUH, IPF, NYN, GZJ |
| Regulation Number | 21 CFR 890.5850, 882.5890 |
| Regulation Class | II |

#### (5) Description/ Design of device:

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes.

The proposed model KTR-405 provides a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands. Modes 1-8 are for foot and can be switched to another mode for a minute automatically, while mode 9 is for knee and mode 10 for body. Modes for foot, knee and body can be switched manually during a session; 2) wonderful electric pulse combination, 0~150 levels can be adjusted and chosen according to personal preference; 3) rechargeable battery which can work up to 36 hours 4) wireless and rechargeable remote control allows easy control of the device 5) use while seated or reclining with Relax and Recline mode; 6)foot cover helps keep feet warm and cosy; 7) LCD display and power display make the operation simple and easy; 8) carry handle for easy transportation; 9) magnetic power cable for simple and safe connection.

Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it can be run either from the mains power supply or via its internal rechargeable battery. To start therapy, you need to connect the device to the mains power supply. This will charge the battery, allowing you to use the device wirelessly in subsequent sessions. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.

#### (6) Intended use / indications:

1) When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:

· for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping

- · to temporarily increase local blood circulation in healthy leg muscles
- · to stimulate healthy muscles in order to improve and facilitate muscle performance

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· to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

- to relax muscle spasm
- to increase blood flow circulation
- for prevention of retardation of disuse atrophy
- for muscle re-education
- · for maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- · Provide quadricep strengthening
- · Improve knee stability secondary to quadricep strengthening

2) When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

- · symptomatic relief and management of chronic, intractable pain
- relief of pain associated with arthritis

· temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

#### (7) Materials

| Component name | Material of<br>Component | Body Contact<br>Category | Contact Duration |
|----------------|--------------------------------------|--------------------------|--------------------|
| Electrode pads | EVA foam, carbon film, hydrogel, PET | Surface skin contact | Less than 24 hours |
| Foot pads | Silica gel | Surface skin contact | Less than 24 hours |

We have directly purchased the electrode pads from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been legally marketed to US market. Also we've conducted biocompatibility tests for foot pads and all pass. For details, please refer to "Biocompatibility Discussion".

## (8) Technological characteristics and substantial equivalence

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| Item | Subject device | Predicate device | Remark |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Trade name | Transcutaneous Electrical<br>Nerve Stimulator<br>Model: KTR-405 | Revitive Medic Coach<br>Model: 5575AQ | / |
| 510 (k) number | K220998 | K210825 | / |
| Regulation number | 21 CFR 882.5890, 890.5850 | 21 CFR 882.5890, 890.5850 | Same |
| Regulation description | Transcutaneous electrical nerve<br>stimulator for pain relief;<br>powered muscle stimulator | Transcutaneous electrical<br>nerve stimulator for pain<br>relief; powered muscle<br>stimulator | Same |
| Product code | NUH, NGX, IPF, NYN, GZJ | NGX, NUH, IPF, NYN, GZJ | Same |
| Class | II | II | Same |
| Indications for use/<br>Intended use | 1) When using Electrical<br>Muscle Stimulation,<br>Transcutaneous Electrical<br>Nerve Stimulator is intended:<br>• for users with conditions or<br>disease that are associated<br>with impaired (poor) blood<br>flow in the legs/ ankles/ feet,<br>the device through the<br>foot-pads is intended for use<br>as an adjunctive treatment (as<br>an addition to your existing<br>treatment) to temporarily<br>reduce lower extremity pain,<br>swelling and cramping<br>• to temporarily increase<br>local blood circulation in<br>healthy leg muscles<br>• to stimulate healthy<br>muscles in order to improve<br>and facilitate muscle<br>performance<br>• to temporarily relieve pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, upper<br>extremities (arms) and lower<br>extremities (legs) due to strain<br>from exercise or normal<br>household duties<br>• to relax muscle spasm | When using Electrical Muscle<br>Stimulation (NMES),<br>Revitive is intended:<br>• for users with conditions or<br>disease that are associated<br>with impaired (poor) blood<br>flow in the legs/ ankles/ feet,<br>NMES though the foot-pads<br>is intended for use as an<br>adjunctive treatment (as an<br>addition to your existing<br>treatment) to temporarily<br>reduce lower extremity pain,<br>swelling and cramping<br>•to temporarily increase local<br>blood circulation in healthy<br>leg muscles<br>•to stimulate healthy muscles<br>in order to improve and<br>facilitate muscle performance<br>•to temporarily relieves pain<br>associated with sore and<br>aching muscles in the<br>shoulder, waist, back, upper<br>extremities (arms) and lower<br>extremities(legs)<br>due to strain from exercise or<br>normal household duties<br>•for relaxation of muscle<br>spasm,<br>•for increase of blood flow | Same |
| | to increase blood flow circulation | circulation, for prevention of retardation | |
| | for prevention of | of disuse atrophy, | |
| | retardation of disuse atrophy | for muscle re-education, | |
| | for muscle re-education | for maintaining or | |
| | for maintaining or | increasing range of | |
| | increasing range of motion | motion,and | |
| | Immediate post-surgical | Immediate post-surgical | |
| | stimulation of calf muscles to | stimulation of calf muscles to | |
| | prevent venous thrombosis | prevent venous thrombosis | |
| | Provide quadricep | Provide quadricep | |
| | strengthening | strengthening | |
| | Improve knee stability | Improve knee stability | |
| | secondary to quadricep | secondary to quadricep | |
| | strengthening | strengthening | |
| | 2) When using | (2) When using Revitive to | |
| | Transcutaneous Electrical | deliver Transcutaneous | |
| | Nerve Stimulator to deliver | Electrical Nerve Stimulation | |
| | Transcutaneous | (TENS), it is intended to | |
| | Nerve Stimulation (TENS), it | provide: | |
| | is intended to provide: | symptomatic relief and | |
| | symptomatic relief and | management of chronic, | |
| | management of chronic, | intractable pain | |
| | intractable pain | relief of pain associated with | |
| | relief of pain associated | arthritis | |
| | with arthritis | temporarily relieves pain…