(142 days)
No
The device description focuses on standard electrical stimulation technology with pre-set modes and adjustable intensity, and there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to alleviate conditions or diseases, such as reducing pain, increasing blood circulation, relaxing muscle spasms, and preventing disuse atrophy, which are therapeutic uses.
No
The device's intended uses focus on therapeutic relief and muscle stimulation (e.g., pain relief, increased circulation, muscle re-education), not on diagnosing a condition.
No
The device description clearly outlines hardware components such as the host, electrode patches, rechargeable battery, remote control, foot cover, LCD display, carry handle, and magnetic power cable. It also describes the physical delivery of electric pulses through electrodes.
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 this device delivers electrical pulses to the user's skin through electrodes. It is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS).
- Intended Use: The intended uses listed are all related to applying electrical stimulation to the body for therapeutic purposes (pain relief, muscle stimulation, circulation improvement, etc.). None of the intended uses involve testing samples from the body.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- 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
- 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
Product codes (comma separated list FDA assigned to the subject device)
NUH, NGX, IPF, NYN, GZJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
legs/ ankles/ feet, shoulder, waist, back, upper extremities (arms), lower extremities (legs), calf muscles, knee
Indicated Patient Age Range
Adult
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testings have been conducted to verify that the Transcutaneous Electrical Nerve Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The body-contacting components of this device are electrode patches and footpads. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. The footpads have been tested for biocompatibility by reliable third-party lab. So we have reason to believe that the electrode patches are safe for the users. The electrode patches and foot pads comply with the following standards. - ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted: - Software verification and validation test according to the requirements of the FDA "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use
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 the FDA logo, which 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.
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.
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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known) K220998
Device Name
Transcutaneous Electrical Nerve Stimulator, Model: KTR-405
Indications for Use (Describe)
-
- 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
- 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
| Street, Longgang District, Shenzhen City, Guangdong | |
| Province,China | |
| Contact person: | Zewu Zhang |
| Phone number: | +86 755 3382 5998 |
| Fax number: | +86 755 3382 5996 |
| Email: | 522378976@qq.com |
| 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; |
| Stimulator, Muscle, Powered, For Muscle Conditioning; | |
| Stimulator, Muscle, Powered; | |
| Stimulator, Electrical, Transcutaneous, For Arthritis; | |
| 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 |
| Model: 5575AQ |
4
| 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:
- 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
5
· 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
- 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
Component | Body Contact
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
6
| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Trade name | Transcutaneous Electrical | ||
| Nerve Stimulator | |||
| Model: KTR-405 | Revitive Medic Coach | ||
| 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 | ||
| stimulator for pain relief; | |||
| powered muscle stimulator | Transcutaneous electrical | ||
| nerve stimulator for pain | |||
| relief; powered muscle | |||
| stimulator | Same | ||
| Product code | NUH, NGX, IPF, NYN, GZJ | NGX, NUH, IPF, NYN, GZJ | Same |
| Class | II | II | Same |
| Indications for use/ | |||
| 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 | When using Electrical Muscle | ||
| Stimulation (NMES), | |||
| Revitive is intended: | |||
| • for users with conditions or | |||
| disease that are associated | |||
| with impaired (poor) blood | |||
| flow in the legs/ ankles/ feet, | |||
| NMES though 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 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 | |||
| •for relaxation of muscle | |||
| spasm, | |||
| •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 | ||
| temporarily relieves pain | associated with sore and | ||
| associated with sore and | aching muscles in the | ||
| aching muscles in the | shoulder, waist, back, upper | ||
| shoulder, waist, back, upper | extremities (arms) and lower | ||
| extremities (arms) and lower | extremities (legs) due to strain | ||
| extremities (legs) due to strain | from exercise or normal | ||
| from exercise or normal | household duties | ||
| household duties | |||
| Patient population | Adult | Not publicly available | / |
| OTC or prescription | OTC | OTC | Same |
| Basic unit specification | |||
| Power supply | Adaptor Input: 100-240AC, 50-60Hz, 0.2A | ||
| Output:5V, 1A | |||
| Unit Input: 5V, 1A | Not publicly available | / | |
| Leakage current | No earth leakage current | Not publicly available | / |
| Number of output | |||
| modes | 10 | Not publicly available | / |
| Number of output | |||
| channel | 2 | Not publicly available | / |
| Output intensity | |||
| level | 150 | Not publicly available | / |
| -Synchronous or | |||
| Alternating? | Synchronous | Not publicly available | / |
| Software/ | |||
| Firmware/ | |||
| Microprocessor | |||
| Control? | Yes | Not publicly available | / |
| Automatic | |||
| Overload | |||
| trip | No | Not publicly available | / |
| Automatic no-load | |||
| trip | No | Not publicly available | / |
| Patient override | |||
| control method | On/Off button | Not publicly available | / |
| Indicator display | |||
| -On/Off status | |||
| -Low battery | |||
| -Output mode | |||
| -Time to cut-off | Yes | ||
| Yes | |||
| Yes | |||
| Yes | Not publicly available | / | |
| Automatic Shut | |||
| Off | Yes | Not publicly available | / |
| Dimensions (in | |||
| mm) | 330 (W) x 327 (H) x 92 (D) | Not publicly available | / |
| Weight | 1.5Kg (Without accessories) | Not publicly available | / |
| Housing material | |||
| and construction | ABS | Not publicly available | / |
| Compliance with | |||
| voluntary | |||
| standards | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-2-10 | |||
| IEC 60601-1-11 | |||
| ISO10993-5 | |||
| ISO10993-10 | Not publicly available | / | |
| Compliance with | |||
| 21CFR 882 and | |||
| 890 | Yes | Not publicly available | / |
| Output specifications | |||
| Waveform | Biphasic, Pulsed symmetric, rectangular wave | Not publicly available | / |
| Net Charge (per pulse) | 0 | Not publicly available | / |
| Maximum Phase Charge (@500Ω) | Footpads: 52.9µC | ||
| Arthro-Kentro pads: 24.18µC | |||
| TENS pads: 9.8µC | Not publicly available | / | |
| Maximum Average Current(@500Ω) | Footpads: 8.31mA | ||
| Arthro-Kentro pads: 4.67mA | |||
| TENS pads: 6.85mA | Not publicly available | / | |
| Maximum current density (@500Ω) | Footpads: 0.041mA/cm² | ||
| Arthro-Kentro pads: 0.039mA/cm² | |||
| TENS pads: 0.132mA/cm² | Not publicly available | / | |
| Maximum power density (@500Ω) | Footpads: 0.00017W/cm² | ||
| Arthro-Kentro pads: 0.00009W/cm² | |||
| TENS pads: 0.00045W/cm² | Not publicly available | / | |
| Pulse frequency | 1Hz-100Hz (±5%) | Not publicly available | / |
| Pulse duration | TENS: 100-120µs | ||
| EMS: 370-400µs and 950µs | Not publicly available | / |
7
8
9
(9) Non-clinical studies and tests performed:
Non-clinical testings have been conducted to verify that the Transcutaneous Electrical Nerve Stimulator meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device. The testing results demonstrate that the subject device complies with the following standards:
- A IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
10
- IEC 60601-1-11, Medical electrical equipment -- Part 1-11: General requirements for A basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
-
IEC 60601-2-10, Medical electrical equipment -- Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
The body-contacting components of this device are electrode patches and footpads. We have directly purchased the electrode patches from qualified supplier which has obtained FDA clearance with a 510(k) number of K171381 and been marketed to US market. The footpads have been tested for biocompatibility by reliable third-party lab. So we have reason to believe that the electrode patches are safe for the users. The electrode patches and foot pads comply with the following standards.
- A ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests for InVitro Cytotoxicity
- A ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
We have also conducted:
- Software verification and validation test according to the requirements of the FDA A "Guidance for Pre Market Submissions and for Software Contained in Medical Devices"
- The waveform test report has also been conducted to verify the output specifications A of the device according to Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use
(10) Clinical information
Not applicable.
(11) Conclusion
Based on the above analysis and non-clinical tests performed, it can be concluded that subject device Transcutaneous Electrical Nerve Stimulator is as safe, as effective and performs as well as the legally marketed predicate device.