Nerve and Muscle Stimulator

K193275 · Shenzhen Xft Medical Limited · IPF · Apr 11, 2020 · Physical Medicine

Device Facts

• Record ID: K193275
• Device Name: Nerve and Muscle Stimulator
• Applicant: Shenzhen Xft Medical Limited
• Product Code: IPF · Physical Medicine
• Decision Date: Apr 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency < 5Hz or > 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities. Prescription Use: XFT-2000 is intended for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Device Story

XFT-2000 is a dual-channel nerve and muscle stimulator utilizing NMES and TENS principles. Device inputs include user-selected programs (15 total) via interface; outputs are electrical pulses delivered through self-adhesive electrodes. Powered by DC adapter or 3 AAA batteries. Used in home or clinical settings by patients or clinicians. Device transforms inputs into biphasic, rectangular pulsed waveforms to stimulate nerves or muscles. Output affects clinical decision-making by providing symptomatic pain relief, muscle strengthening, or post-surgical rehabilitation. Benefits include pain management, improved muscle performance, and prevention of venous thrombosis. Device is neither life-supporting nor implantable.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), performance requirements for nerve/muscle stimulators (IEC 60601-2-10), and biocompatibility (ISO 10993-5/10).

Technological Characteristics

Materials: Silicone and ABS. Sensing/Actuation: NMES/TENS electrical stimulation. Energy: DC adapter or 3 AAA batteries. Dimensions: 114x66x20mm. Connectivity: Standalone. Software: Microprocessor-controlled with 15 programs. Safety: Automatic overload/no-load trip, automatic shut-off, patient pause control. Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993.

Indications for Use

Indicated for OTC use for temporary relief of pain from sore/aching muscles (strain/exercise/household), chronic intractable pain, and arthritis pain. Indicated for NMES to improve muscle tone/firmness/strength in arms, abdomen, legs, buttocks, and increase local blood circulation in healthy lower extremity muscles. Indicated for prescription use for muscle spasm relaxation, disuse atrophy prevention, muscle re-education, post-surgical calf stimulation to prevent venous thrombosis, range of motion maintenance, and adjunctive management of post-surgical/post-traumatic acute pain.

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

• MediStim XP, Type 281 (K082011)
• Electronic Pulse Stimulator (K162517)

Submission Summary (Full Text)

{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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 11, 2020

Shenzhen XFT Medical Limited % Field Fu Senior Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122#, International Mayors Communication Centre NO. 55 Shizhou middl Shenzhen, Guangdong, China Re: K193275 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, GZJ Dated: January 6, 2020 Received: January 13, 2020

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 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

{1}------------------------------------------------

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 Vivek Pinto, PhD 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K193275

Device Name Nerve and Muscle Stimulator

Indications for Use (Describe) Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency < 5Hz or > 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]:

XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.

Prescription Use:

XFT-2000 is intended for the following use:

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
- Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

{3}------------------------------------------------

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 [e-mail]

"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."

{4}------------------------------------------------

## 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.

### 5.1 Administrative Information

| Date of Summary<br>prepared | Oct. 23, 2019 |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer<br>information | Company title: Shenzhen XFT Medical Limited. |
| | 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: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |
| Submission<br>Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: 1713A, 17th Floor, Block A,<br>Zhongguan Times Square, Liuxian Avenue, Xili |
| | Town, Nanshan District, Shenzhen, Guangdong<br>Province, China. |
| | Contact person: Mr. Field Fu |
| Image: logo | E-Mail: [e-mail]; |
| Establishment<br>registration number | |

## 5.2 Device Information

| Type of 510(k)<br>submission: | Traditional |
|-------------------------------|----------------------------------|
| Trade Name: | Nerve and Muscle Stimulator |
| Model: | XFT-2000 |
| | Stimulator, Muscle, Powered; |
| Classification<br>name: | Stimulator, Nerve, |
| | Transcutaneous, For Pain Relief. |

{5}------------------------------------------------

| Review Panel: | Physical Medicine; Neurology. |
|--------------------|-------------------------------|
| Product Code: | IPF; GZJ. |
| Device Class: | II |
| Regulation Number: | 890.5850; 882.5890. |

### 5.3 Predicate Device Information

| Sponsor: | Rio-Medical Research Ltd. |
|----------------|-----------------------------|
| Device: | MediStim XP, Type 281; |
| 510(K) Number: | K082011 |
| Sponsor: | JKH Health Co., Ltd. |
| Device: | Electronic Pulse Stimulator |
| 510(K) Number: | K162517 |

### 5.4 Device Description

Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems.

Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode.

The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

## 5.5 Intended Use/ Indications for Use

### Over-The-Counter Use:

TENS[ (Program 1~9, Program 15 (Frequency<5Hz or >15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

{6}------------------------------------------------

XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities.

#### Prescription Use:

XFT-2000 is intended for the following use:

- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion

- Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

## 5.6 Technological characteristics of the subject device compared to the predicate device

See next pages.

{7}------------------------------------------------

| Elements of<br>Comparison | Subject Device | Predicate Device | Predicate Device | Remarks | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|------|
| 510(k) Number | K193275 | K082011 | K162517 | | |
| Manufacturer | Shenzhen XFT<br>Medical Limited | Rio-Medical<br>Research Ltd | JKH USA, LLC | | |
| Device<br>type/model | XFT-2000 | Medistim XP Type 281; | PL-029K12; | / | |
| Intended use/<br>Indication<br>for<br>use | Neuromuscular<br>Electrical Stimulation<br>(NMES) for relaxation<br>of muscle spasms,<br>prevention or<br>retardation of disuse<br>atrophy, increasing<br>local blood circulation,<br>muscle re-education,<br>immediate post-<br>surgical stimulation of<br>calf muscles to prevent<br>venous thrombosis<br>and maintaining or<br>increasing range of<br>motion.<br>Transcutaneous<br>Electrical Nerve<br>Stimulation (TENS) for<br>an adjunctive<br>treatment in the<br>management of post-<br>surgical and post-<br>traumatic acute pain<br>problems. | Medistim XP delivers<br>stimulation based on the<br>principles of<br>Neuromuscular Electrical<br>NerveStimulation<br>(NMIES) and also<br>Transcutaneous<br>Electrical Nerve<br>Stimulation (TENS).<br>Theindications for use<br>are as follows:<br>Neuromuscular Electrical<br>Stimulation for relaxation<br>ofmuscle spasms,<br>prevention or retardation<br>of disuse atrophy,<br>increasing local blood<br>circulation,muscle re-<br>education, immediate<br>post-surgical stimulation<br>of calf muscles to<br>prevent venousthrombosis and<br>maintaining or increasing<br>range of motion.<br>Transcutaneous<br>Electrical<br>NerveStimulation<br>(TENS) for an adjunctive<br>treatment in the<br>management of post-<br>surgical and post-<br>traumatic acute pain<br>problems. | TENS (Modes 1, 2, 4,<br>5, 6, 8):<br>To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, arm, and leg,<br>due to strain from<br>exercise or normal<br>household and work<br>activities.<br>It is also intended for<br>symptomatic relief and<br>management of<br>chronic, intractable<br>pain and relief of pain<br>associated with<br>arthritis.<br>PMS (also called EMS,<br>Modes 1, 3, 7):<br>To stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance.<br>To be used for the<br>improvement of muscle<br>tone and firmness, and<br>for strengthening<br>muscles in the arms,<br>abdomen, legs, and<br>buttocks. Not intended<br>for use in any therapy<br>or for the treatment of | SE | |
| Elements of<br>Comparison | Subject Device | Predicate Device | Predicate Device | Remarks | |
| | | | any medical conditions<br>or diseases.<br>t is also intended to<br>temporarily increase<br>local blood circulation<br>in the healthy muscles<br>of lower extremities. | | |
| Prescription<br>or<br>OTC | Prescription and OTC | Prescription | OTC | SE | |
| Electrode | 5cm round;K132588 | 5×5cm;7cm round;<br>5cm×9cm etc.<br>K970426,<br>K874469,K965194 | unknown | SE | |
| Waveform | Pulsed,Symmetrical<br>balanced biphasic<br>wave (rectangular) | Pulsed, Symmetrical<br>Biphasic, Rectangular<br>with interphase interval | Biphasic, Rectangular | SE | |
| Performance | Compliance with IEC<br>60601-2-10 | Compliance with IEC<br>60601-2-10 | Compliance with IEC<br>60601-2-10 | Same | |
| Biocompatibility | All the patient<br>contacting materials<br>are compliance with<br>ISO 10993-1/-5/-10 | All the patient contacting<br>materials are<br>compliance with ISO<br>10993-1/-5/-10 | All the patient<br>contacting materials<br>are compliance with<br>ISO 10993-1/-5/-10 | Same | |
| Electrical Safety | Compliance with IEC<br>60601-1 | Compliance with IEC<br>60601-1 | Compliance with IEC<br>60601-1 | Same | |
| EMC | Compliance with IEC<br>60601-1-2 | Compliance with IEC<br>60601-1-2 | Compliance with IEC<br>60601-1-2 | Same | |
| Connecting<br>Safety | 21CFR 898 | 21CFR 898 | 21CFR 898 | Same | |
| Parameter | Subject Device | Predicate Device | Predicate Device | Remarks | |
| 510(k) Number | K193275 | K082011 | K162517 | / | |
| Device Name and<br>Model | Nerve and Muscle<br>Stimulator, XFT-<br>2000 | MediStimi XP, Type<br>281 | JKH Stimulator:<br>PL-029K12, | / | |
| Manufacturer | Shenzhen XFT<br>Medical Limited | Rio-Medical<br>Research Ltd | JKH USA, LLC | / | |
| Power Source(s) | DC4.5V, 3 × AAA<br>batteries;<br>DC Adapter. | 9V Battery (type<br>6LR61) | Rechargeable or<br>non-rechargeable<br>battery | Note 01 | |
| ---Method of Line Current<br>Isolation | Battery Supply, or<br>DC Adapter | Battery Supply | Battery Supply | Note 01 | |
| ---Patient Leakage Current:<br>Normal Condition (µA) | N/A | N/A | N/A | / | |
| ---Patient Leakage Current:<br>Single Fault Condition (µA) | N/A | N/A | N/A | / | |
| Number of Output<br>Modes(programs) | 15 | 9 | 8 | Note 02 | |
| Number of Output Channels: | 2 | 2 | 1 | SE | |
| ---Synchronous or Alternating? | Both | Synchronous(Multip<br>lexed) | N/A | SE | |
| ---Method of Channel Isolation | Transistor | Transistor | N/A | SE | |
| Regulated Current or<br>Regulated Voltage? | Regulated Current | Regulated Current | Regulated Voltage | SE | |
| Software/Firmware/Microproce<br>ssor Control? | Yes | Yes…