Nerve and Muscle Stimulator
Device Facts
| Record ID | K211094 |
|---|---|
| Device Name | Nerve and Muscle Stimulator |
| Applicant | Shenzhen Xft Medical Limited |
| Product Code | IPF · Physical Medicine |
| Decision Date | Jul 8, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5850 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
sEMG: Biofeedback, Relaxation & Muscle Re-Education purposes; NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode): 1) Relaxation of muscle spasms; 2) Prevention or retardation of disuse atrophy; 3) Increasing local blood circulation; 4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; 5) Maintaining or increasing range of motion; 6) Stroke Rehab by Muscle re-education.
Device Story
Nerve and Muscle Stimulator (XFT-2003K) is an electrical muscle stimulator and electromyography (sEMG) device; monitors/displays bioelectric signals from muscles/nerves; provides NMES, ETS, PAS, and MIRROR stimulation modes. Used in clinical settings by healthcare professionals for prescription-based therapy. Device inputs include sEMG signals via electrode cups; transforms inputs into electrical stimulation outputs based on selected programs. Output helps clinicians monitor muscle activity and deliver therapeutic stimulation to facilitate muscle re-education, spasm relaxation, and circulation. Benefits include improved range of motion, atrophy prevention, and stroke rehabilitation support. Device is AC-powered (100-240V).
Clinical Evidence
No clinical data. Bench testing only, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance standards for nerve/muscle stimulators (IEC 60601-2-10) and electromyographs (IEC 60601-2-40). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.
Technological Characteristics
Powered by AC mains (100-240V, 50-60Hz). Uses electrode cups with sponges. Features dual-channel output with transformer isolation. Waveform: pulsed, symmetrical balanced biphasic (rectangular). Includes microprocessor control, automatic overload/no-load trip, and patient override. Biocompatible materials per ISO 10993. Compliance with IEC 60601-1, 60601-1-2, 60601-2-10, 60601-2-40, and 21 CFR 898.
Indications for Use
Indicated for patients requiring muscle re-education, relaxation, biofeedback, spasm relaxation, prevention of disuse atrophy, increased local blood circulation, post-surgical calf muscle stimulation to prevent venous thrombosis, maintenance/increase of range of motion, and stroke rehabilitation.
Regulatory Classification
Identification
A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Predicate Devices
- MYOTRAC INFINITI (K053266)
Reference Devices
Submission Summary (Full Text)
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July 8, 2021
Shenzhen XFT Medical Limited % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong China
Re: K211094
Trade/Device Name: Nerve and Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, HCC Dated: April 6, 2021 Received: April 12, 2021
Dear Field Fu:
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.
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
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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,
Patrick Antkowiak Acting Assistant Director 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) K211094
Device Name Nerve and Muscle Stimulator
#### Indications for Use (Describe)
sEMG:
Biofeedback, Relaxation & Muscle Re-Education purposes;
NMES (muscle stimulation) and sEMG triggered stimulation (IncludingETS, PAS and MIRROR Mode):
- 1) Relaxation of muscle spasms;
2) Prevention or retardation of disuse atrophy;
- 3) Increasing local blood circulation:
- 4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
- 5) Maintaining or increasing range of motion;
6) Stroke Rehab by Muscle re-education.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Shenzhen XFT Medical Limited | 510(K) Summary |
|--------------------------------------|----------------|
| Product: Nerve and Muscle Stimulator | Version: A/1 |
# 510(k) Summary
This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
## 1 Administrative Information
| Date of Summary<br>prepared<br>Manufacturer<br>information | Apr., 6, 2021<br>Shenzhen XFT Medical Limited.<br>Company address:<br>Room 203, Building 1, Biomedicine Innovations<br>Industrial Park, #14 Jinhui Road, Pingshan New<br>District, Shenzhen, China.<br>Contact person: Cindy Peng<br>Phone: +86 755 29888818<br>Fax: +86-0755-28312625<br>E-mail: xftrs2@xft.cn |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission<br>Correspondent<br>Image: logo | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: 1713A, 17th Floor, Block A,<br>Zhongguan Times Square, Liuxian Avenue, Xili<br>Town, Nanshan District, Shenzhen, Guangdong<br>Province, China.<br>Contact person: Mr. Field Fu<br>E-Mail: field@cefda.com; |
| Establishment<br>registration number | |
### 2 Device Information
| Type of 510(k)<br>submission: | Traditional |
|-------------------------------|----------------------------------------------------------------------------------------|
| Trade Name: | Nerve and Muscle Stimulator |
| Model: | XFT-2003k |
| Classification name: | Stimulator, Muscle, Powered;<br>Stimulator, Nerve,<br>Transcutaneous, For Pain Relief. |
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Product: Nerve and Muscle Stimulator
| Review Panel: | Physical Medicine; Neurology. |
|--------------------|-------------------------------|
| Product Code: | IPF; HCC. |
| Device Class: | II |
| Regulation Number: | 890.5850 |
### 3 Predicate Device Information
| Sponsor: | Thought Technology Ltd. |
|----------------|--------------------------------------------------|
| Device: | Powered muscle stimulator and biofeedback device |
| Device#: | SA9800 |
| Trade name: | MYOTRAC INFINITI |
| 510(K) Number: | K053266 |
### 4 Device Description
The Nerve and Muscle Stimulator (model: XFT-2003K) is an electrical muscle stimulator for contraction of muscles as indicated above. The Nerve and Muscle Stimulator (model: XFT-2003K) is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle reeducation, relaxation and biofeedback.
Nerve and Muscle Stimulator (model: XFT-2003K) is powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used together with Electrode cup (including Sponge).
The device is used for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.
### 5 Intended Use/ Indications for Use
### sEMG:
Biofeedback, Relaxation & Muscle Re-Education purposes;
## NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode):
1) Relaxation of muscle spasms;
2) Prevention or retardation of disuse atrophy;
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| Shenzhen XFT Medical Limited | 510(K) Summary |
|--------------------------------------|----------------|
| Product: Nerve and Muscle Stimulator | Version: A/1 |
3) Increasing local blood circulation;
4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
5) Maintaining or increasing range of motion;
6) Stroke Rehab by Muscle re-education.
## 6 Technological characteristics of the subject device compared to the predicate device
| Elements of<br>Comparison | Subject Device | Predicate Device | Remarks |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) Number | Pending | K053266 | |
| Manufacturer | Shenzhen XFT Medical<br>Limited | Thought Technology Ltd. | |
| Device<br>type/model | XFT-2003K | MYOTRAC INFINITI | / |
| Intended use/<br>Indication<br>for<br>use | sEMG:<br>Biofeedback, Relaxation &<br>Muscle Re-Education<br>purposes;<br>NMES (muscle stimulation)<br>and sEMG triggered<br>stimulation (IncludingETS,<br>PAS and MIRROR Mode):<br>1) Relaxation of muscle<br>spasms;<br>2) Prevention or retardation of<br>disuse atrophy;<br>3) Increasing local blood<br>circulation;<br>4) Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis;<br>5) Maintaining or increasing<br>range of motion;<br>6) Stroke Rehab by Muscle re-<br>education. | 1) Biofeedback, Relaxation and<br>Muscle Re-Education purposes;<br>2) Relaxation of muscle spasms;<br>3) Prevention or retardation of<br>disuse atrophy;<br>4) Increasing local blood<br>circulation;<br>5) Immediate post-surgical<br>stimulation of calf muscles to<br>prevent venous thrombosis;<br>6) Maintaining or increasing<br>range of motion.<br>7) Stroke Rehab by Muscle re-<br>education. | SE |
| Prescription<br>or<br>OTC | RX | RX | SE |
| Electrode | EC002: 25.57cm²;<br>EC001: 9.621cm²; | Axelgaard Model 895340:<br>75 cm²;<br>Axelgaard Model 895220:<br>25cm²; | Note 01 |
# Table 01: SE Comprehensive Comparison Table
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#### 510(K) Summary
### Product: Nerve and Muscle Stimulator
Version: A/1
| Elements of<br>Comparison | Subject Device | Predicate Device | Remarks |
|---------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|---------|
| Waveform | Pulsed,Symmetrical balanced<br>biphasic wave (rectangular) | Asymmetrical balanced pulsed<br>current | SE |
| Performance | Compliance with IEC 60601-<br>2-10 | Compliance with IEC 60601-2-<br>10 | Same |
| Biocompatibility | All the patient contacting<br>materials are in compliance<br>with ISO 10993-1/-5/-10 | All the patient contacting<br>materials are in compliance with<br>ISO 10993-1/-5/-10 | Same |
| Electrical Safety | Compliance with IEC 60601-1 | Compliance with IEC 60601-1 | Same |
| EMC | Compliance with IEC 60601-<br>1-2 | Compliance with IEC 60601-1-2 | Same |
| Connecting<br>Safety | 21CFR 898 | 21CFR 898 | Same |
Note 01: Maximum Current Density and Maximum Power Density are equivalent respectively.
# Table 02: SE General Specification Comparison Table
| Parameter | Subject Device | Predicate Device | Remarks |
|------------------------------------------------------------|---------------------------------|-------------------------------------------------------------------------|---------|
| 510(k) Number | Pending | K053266 | / |
| Device Name and<br>Model | XFT-2003K | MYOTRAC INFINITI | / |
| Manufacturer | Shenzhen XFT Medical<br>Limited | Thought Technology Ltd. | / |
| Power Source(s) | AC 110-240 50-60Hz | 4 AAA batteries, single use<br>alkaline or Rechargeable<br>battery pack | Note 02 |
| ---Method of Line Current<br>Isolation | 2MOPP | 2MOPP | Same |
| ---Patient Leakage Current:<br>Normal Condition (μΑ) | $\u22641$ | $\u22641$ | Same |
| ---Patient Leakage Current:<br>Single Fault Condition (μΑ) | $\u22641$ | $\u22641$ | Same |
| Number of Output<br>Modes(programs) | 4 | 2 | SE |
| Number of Output Channels: | Double | Double | Same |
| ---Synchronous or Alternating? | Synchronous | Synchronous | Same |
| ---Method of Channel Isolation | Transformer | Transformer | Same |
| Regulated Current or Regulated<br>Voltage? | Regulated Current | Regulated Voltage | SE |
| Software/Firmware/Microproces | Yes | Yes | Same |
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Product: Nerve and Muscle Stimulator
Version: A/1
| Parameter | Subject Device | Predicate Device | Remarks | |
|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| sor Control? | | | | |
| Automatic Overload<br>Trip? | Yes | Yes | Same | |
| Automatic No-Load Trip? | Yes | Yes | Same | |
| Automatic Shut Off? | Yes | No | SE | |
| Patient Override Control? | Yes | Yes | Same | |
| Indicator<br>Display: | On/Off Status? | yes | Yes | Same |
| | Low Battery? | No. | Yes | Note 03 |
| | Voltage/Current<br>Level? | Yes | Yes | Same |
| Timer Range (minutes) | | 1-60min, step 1min | 1-120min | SE |
| sEMG detection | | Bipolar | Bipolar | same |
| sEMG range (μ V) | | 1-2000 | 0-5, 0-10, 5-10, 0-20, 5-20,<br>10-20, 0-50, 10-50, 0-100,<br>50-100,0-200, 50-200, 100-<br>200, 0-500,100-500, 0-<br>1000, 0-2000 | SE |
| Feedback response frequency<br>bands(Hz) | | 20-500 | 20-500 | Same |
| sEMG indication accuracy | | $±10%or±2 μ V$ ,<br>whichever is greater | unknown | The<br>triggering<br>of electrical<br>stimulation<br>is not<br>adverse |
| Feedback threshold | | $±10%or±2 μ V$ ,<br>whichever is greater | unknown | affected |
| Compliance with Voluntary<br>Standards? | | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-2-40 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | SE |
| | Compliance with 21 CFR 898 | Yes | Yes | Same |
| Weight | | 3.8kg | 330g | |
| | Dimensions (mm) [W x H x D] | 359×289×202mm | 102*152*51mm | Note 04 |
| Parameter | Subject Device | Predicate Device<br>K053326 | Remarks | |
| Maximum Output<br>Voltage (volts) (+/-<br>20%) | NMES Mode:<br>P1 ~ P6, P8 ~ P10,<br>P12 ~ P29, P33, P37,<br>P39, P41 ~P42. | 50V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | SE<br>The NMES<br>Modeof the<br>Subject Device<br>is compared to<br>the STIMMode<br>of the<br>Predicate<br>Device. |
| | NMES Mode:<br>P7, P11, P30, P34. | 48.4V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | |
| | NMES Mode:<br>P31. | 34.2V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | The ETS |
| | NMES Mode:<br>P32, P36, P40. | 41.9V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | Mode of the<br>Subject Device<br>is compared to<br>the Threshold |
| | NMES Mode:<br>P35. | 39.5V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | Mode of the<br>Predicate<br>Device. |
| | NMES Mode:<br>P38. | 44.8V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | The PAS<br>Mode of the<br>Subject Device<br>is compared to<br>the Triggered<br>Mode of the<br>Predicate<br>Device. |
| | NMES Mode:<br>P43. | 15V@500Ω<br>60V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | |
| | ETS Mode. | 23.7V@500Ω<br>94.6V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | The Mirror<br>Mode of the<br>Subject Device<br>is compared to<br>the Triggered<br>Mode of the<br>Predicate<br>Device. |
| | PAS Mode. | 50V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | |
| | MIRROR Mode. | 50V@500Ω<br>125V@ 2 kΩ<br>125V@10 kΩ | 50V@ 500 Ω<br>100V@ 2 kΩ<br>100V@ 10 kΩ | |
| Maximum Output<br>Current (specify<br>units)<br>(+/-<br>20%) | NMES Mode:<br>P1~P6, P8 ~ P10,<br>P12~ P29, P33, P37,<br>P39, P41~P42. | 100mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | SE<br>The NMES<br>Modeof the<br>Subject Device<br>is compared to<br>the STIMMode<br>of the<br>Predicate<br>Device. |
| | NMES Mode:<br>P7, P11, P30, P34. | 96.8mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | |
| | NMES Mode:<br>P31. | 68.4mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | |
| | NMES Mode: | 83.8mA@500Ω | 100.0mA@500Ω | |
| Parameter | Subject Device | Predicate Device<br>K053326 | Remarks | |
| | P32, P36, P40. | 62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 50mA@ 2 kΩ<br>10mA@10 kΩ | The ETS<br>Mode of the<br>Subject Device<br>is compared to<br>the Threshold<br>Mode of the<br>Predicate<br>Device. |
| | NMES Mode:<br>P35. | 79mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | |
| | NMES Mode:<br>P38. | 89.6mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | |
| | NMES Mode:<br>P43. | 30mA@500Ω<br>30mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | The PAS<br>Mode of the<br>Subject Device<br>is compared to<br>the Triggered<br>Mode of the<br>Predicate<br>Device. |
| | ETS Mode. | 47.4mA@500Ω<br>47.4mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | |
| | PAS Mode. | 100mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | The Mirror<br>Mode of the<br>Subject Device<br>is compared to<br>the Triggered<br>Mode of the<br>Predicate<br>Device. |
| | MIRROR Mode. | 100mA@500Ω<br>62.5mA@ 2 kΩ<br>12.5mA@10 kΩ | 100.0mA@500Ω<br>50mA@ 2 kΩ<br>10mA@10 kΩ | |
| Pulse<br>Duration/width† (use<br>c) | NMES Mode:<br>P1. | 250µs | 50-400µs | SE |
| | NMES Mode:<br>P2, P14, P24. | 150µs | 50-400µs | SE |
| | NMES Mode:<br>P3, P16, P19, P26. | 50µs | 50-400µs | SE |
| | NMES Mode:<br>P4. | 45µs | 50-400µs | SE |
| | NMES Mode:<br>P5~P12, P18, P28, P41,<br>P42.<br>PAS Mode.<br>MIRROR Mode. | 200µs | 50-400µs | SE |
| | NMES Mode:<br>P13, P17, P21~P23, P<br>25,<br>P35. | 300µs | 50-400µs | SE |
| | NMES Mode:<br>P15, P20, P27, P39. | 100µs | 50-400µs | SE |
| | NMES Mode:<br>P29~P34, P36~P38, P<br>40. | 400µs | 50-400µs | SE |
| | NMES Mode:<br>P46. | 50-500µs | 50-400µs | SE |
| Parameter | Subject Device | Predicate Device<br>K053326 | Remarks | |
| Frequency† (Hz) [or<br>Rate† (pps)] | NMES Mode:<br>P1, P5, P9, P13, P17,<br>P21, P25, P29, P33,<br>P37, P41. | 5Hz | 2-100Hz | SE |
| | NMES Mode:<br>P2, P15, P18, P23,<br>P38. | 35Hz | 2-100Hz | SE |
| | NMES Mode:<br>P3, P7, P11, P19, P26,<br>P31,P35, P39. | 60Hz | 2-100Hz | SE |
| | NMES Mode:<br>P4. | 100Hz | 2-100Hz | SE |
| | NMES Mode:<br>P6, P30, P34.<br>MIRROR Mode. | 30Hz | 2-100Hz | SE |
| | NMES Mode:<br>P8. | 45Hz | 2-100Hz | SE |
| | NMES Mode:<br>P10, P12, P16, P20,<br>P24, P27, P28, P32,<br>P36, P40,P42. | 40Hz | 2-100Hz | SE |
| | NMES Mode:<br>P14, P22. | 25Hz | 2-100Hz | SE |
| | NMES Mode:<br>P43. | 2~250Hz | 2-100Hz | SE |
| | ETS Mode. | 2-100Hz | 2-100Hz | SE |
| | PAS Mode. | 18Hz | 2-100Hz | SE |
| For interferential<br>modes only:<br>-Beat Frequency<br>(Hz) | NMES Mode:<br>P1~P43, ETS Mode,<br>PAS Mode,<br>MIRROR Mode. | N/A | N/A | / |
| For Symmetrical<br>multipha phases? | NMES Mode:<br>P1~P43, ETS Mode,<br>PAS Mode,<br>MIRROR Mode. | N/A | N/A | / |
| ms only: Phase<br>Duration† (in<br>clude units),<br>(state range,<br>if applicable),<br>(both<br>phases, if<br>asymmetrical) | NMES Mode:<br>P1~P43, ETS Mode,<br>PAS Mode,<br>MIRROR Mode. | N/A | N/A | / |
| Net Charge<br>(microcoulombs<br>(µC) per pulse) (If<br>zero, state method<br>of achieving zero | NMES Mode:<br>P1~P43, ETS Mode,<br>PAS Mode,<br>MIRROR Mode | 0@500Ω | 0@500Ω | Same |
| Parameter | Subject Device | Predicate Device<br>K053326 | Remarks | |
| net charge.) | | | | |
| Maximum Phase<br>Charge, (µC) | NMES Mode:<br>P1, P6. | 25@500Ω | 60@500Ω | SE |
| | NMES Mode:<br>P2, P14, P24, | 15@500Ω | 60@500Ω | |
| | NMES Mode:<br>P3, P16, P19, P26. | 5@500Ω | 60@500Ω | |
| | NMES Mode:<br>P4,P15, P20, P27,<br>P39. | 10@500Ω | 60@500Ω | |
| | NMES Mode:<br>P5, P8~P10, P12, P18,<br>P28, P41, P42.<br>PAS Mode.<br>MIRROR Mode. | 20@500Ω | 60@500Ω | |
| | NMES Mode:<br>P7, P11. | 19.36@500Ω | 60@500Ω | |
| | NMES Mode:<br>P13, P17, P21~P23,<br>P25. | 30@500Ω | 60@500Ω | |
| | NMES Mode:<br>P29, P33, P37. | 40@500Ω | 60@500Ω | |
| | NMES Mode:<br>P30, P34,. | 38.72@500Ω | 60@500Ω | |
| | NMES Mode:<br>P31. | 27.36@500Ω | 60@500Ω | |
| | NMES Mode:<br>P32, P36, P40. | 33.52@500Ω | 60@500Ω | |
| | NMES Mode:<br>P35. | 23.7@500Ω | 60@500Ω | |
| | NMES Mode:<br>P38. | 35.84@500Ω | 60@500Ω | |
| | NMES Mode:<br>P43.<br>ETS Mode. | 50@500Ω | 60@500Ω | |
| Maximum Current<br>Density,††(mA/cm².) | NMES: P43. | 0.38977@500Ω<br>(EC001)<br>0.14696@500Ω<br>(EC002) | Axelgaard Model<br>895220<br>0.24mA/cm2<br>Axelgaard Model<br>895340<br>0.08mA/cm2 | Note 05 |
| Maximum Power<br>Density,†† (mW/cm²)<br>, (using smallest<br>electrode<br>conductive surface<br>area) | NMES: P30, P34, P43. | 11.69@500Ω<br>(EC001)<br>4.41@500Ω<br>(EC002) | Axelgaard Model<br>895220<br>16mW/cm2<br>Axelgaard Model<br>895340<br>5.3mW/cm2 | Note 06 |
| Parameter | Subject Device | Predicate Device<br>K053326 | Remarks | |
| Burst Mode<br>(i.e., pulse trains): | (a) Pulses per burst | 2~6000 | 4-2000 | Note 07 |
| | (b) Bursts per second | 0.05~1 | 0.05-0.5 | / |
| | (c) Burst duration (seconds) | 1~20 | 2-20 | / |
| | (d) Duty Cycle: Line (b) x Line (c) | 1 | 1 | Same |
| ON Time (seconds) | | 1~20 | 2-20 | / |
| OFF Time (seconds) | | 1~20 | 2-50 | / |
Note 02: DC adaptor meets IEC 60601-1 standard.
Note 03: The subject device is powered by AC, not battery.
Note 04: The subject device is not a portable device.
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510(K) Summary
Product: Nerve and Muscle Stimulator
Version: A/1
# Table 03: SE Detailed Comparison Table
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510(K) Summary
Product: Nerve and Muscle Stimulator
Version: A/1
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510(K) Summary
Product: Nerve and Muscle Stimulator
Version: A/1
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510(K) Summary
Product: Nerve and Muscle Stimulator
Version: A/1
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510(K) Summary
Product: Nerve and Muscle Stimulator
Version: A/1
Note 05: The treatment effect is mainly determined by Maximum Power Density.
Note 06: The Maximum Power Density at this level is effective, for instance, Maximum Power Density is effective when it is as small as 1.38 mW/cm2 (K172933), 1.44 mW/cm2 (K182203, model PL-029K12) , 1.26 mW/cm2 (K182203, model PL-029K13: ), 1.68 mW/cm2 (K191151, model PL-029K15) and even as low as 0. 32 mW/cm2 (K162517, PL-029K12, P3.)
Note 07: subject device's pulses per burst rate is significantly different than the predicate device, but the duty cycle of the subject device is same as the duty cycle of the predicate, so the differences do not affect safety and effectiveness of the subject device.
Maximum Output Voltage, Maximum Output Current, Pulse Duration/width, Frequency range of the subject device are respectively SE to or similar with the predicate; there are little differences between the Maximum Current Density, Maximum Power Density, Burst Mode (i.e., pulse trains) of the subject device and the predicate, but the differences do not exert adverse effect on the proposed device.
## 7 Brief discussion of the nonclinical tests
The subject device conforms to the following standards:
60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 IEC Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential
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| Shenzhen XFT Medical Limited | 510(K) Summary |
|--------------------------------------|----------------|
| Product: Nerve and Muscle Stimulator | Version: A/1 |
Performance.
IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
IEC 60601-2-40:2016 Medical Electrical Equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
IEC 60601-2-10:2016 Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization.
# 8 Brief discussion of clinical tests
N/A.
9 Other information (such as required by FDA guidance/Test) No.
## 10 Conclusions
The subject device has features that are similar to the predicate device. The few differences do not affect the safety and effectiveness of the subject device. Thus, the subject device is substantially equivalent to the predicate device.
