Ultrasound Therapy Workstation (XMS-UET2)

K244041 · Xemis Medical Technology (Shenzhen) Co., Ltd. · IMG · Oct 7, 2025 · Physical Medicine

Device Facts

• Record ID: K244041
• Device Name: Ultrasound Therapy Workstation (XMS-UET2)
• Applicant: Xemis Medical Technology (Shenzhen) Co., Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Oct 7, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is intended for use only in adult patients. Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1) Pain relief, muscle spasms and joint contractures. 2) Relief of pain, muscle spasms and joint contractures that may be associated with: - Adhesive capsulitis - Bursitis with slight calcification - Myositis - Soft tissue injuries - Shortened tendons due to past injuries and scar tissues 3) Relief of sub-chronic, chronic pain and joint contractures resulting from: - Capsular tightness - Capsular scarring For TENS, Interferential, premodulated (IFC), NMS and Microcurrent: 1) Symptomatic relief of chronic intractable pain 2) Post-traumatic acute pain 3) Post-surgical acute pain Additionally for NMS, NMS Burst, Hi-Volt and Russian: 1) Relaxation of Muscle spasms 2) Prevention or retardation of disuse atrophy 3) Increasing local blood circulation 4) Muscle re-education 5) Maintaining or increasing range of motion 6) Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis For DC Continuous Mode 1) Relaxation of muscle spasm

Device Story

Ultrasound Therapy Workstation (XMS-UET2) is an AC-powered device for clinical use (hospitals, clinics, rehab centers) by healthcare professionals. It provides electrotherapy (TENS, IFC, NMS, Microcurrent, Hi-Volt, Russian, DC) and therapeutic ultrasound. Device features color touchscreen and control knob for parameter selection. Software controls all indicators and outputs. Ultrasound module uses piezoelectric crystals to deliver deep heat; electrotherapy module delivers electrical stimulation via electrodes. Device includes pre-set protocols and manual adjustment modes. Output parameters (voltage, current, frequency, pulse width) are software-controlled. Safety features include automatic overload/no-load trips and shut-off. Output affects muscle tissue and nerves to provide pain relief, muscle relaxation, and rehabilitation benefits. Patient safety is managed via operator monitoring and labeling warnings regarding skin irritation/burns.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1), electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing per IEC 60601-2-5 and IEC 60601-2-10.

Technological Characteristics

AC-powered workstation; plastic housing. Ultrasound: piezoelectric crystal transducer, 1/3 MHz, continuous/pulsed modes. Electrotherapy: NMS, TENS, Hi-Volt, Russian, IFC, Microcurrent, DC. Connectivity: standalone. Software-controlled parameters. Sterilization: N/A (non-invasive). Standards: ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-5, IEC 60601-2-10.

Indications for Use

Indicated for adult patients requiring therapeutic deep heat for sub-chronic/chronic pain, muscle spasms, joint contractures, adhesive capsulitis, bursitis, myositis, soft tissue injuries, or shortened tendons. Also indicated for symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain via TENS, IFC, NMS, or Microcurrent. NMS, Hi-Volt, and Russian modes indicated for muscle spasm relaxation, atrophy prevention, circulation improvement, muscle re-education, range of motion maintenance, and post-surgical venous thrombosis prevention.

Regulatory Classification

Identification

An ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies. The device also passes electrical currents through the body area to stimulate or relax muscles.

Predicate Devices

• ComboRehab (K150436)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

October 7, 2025

Xemis Medical Technology (Shenzhen) Co., Ltd.
% Jie Yang
Consultant
Chonconn Consulting Co., Ltd.
Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District
Shenzhen, Guangdong 518067
China

Re: K244041
Trade/Device Name: Ultrasound Therapy Workstation (XMS-UET2)
Regulation Number: 21 CFR 890.5860
Regulation Name: Ultrasound And Muscle Stimulator
Regulatory Class: Class II
Product Code: IMG, GZI, GZJ, IPF, LIH
Dated: December 30, 2024
Received: August 25, 2025

Dear Jie Yang:

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 (the 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 available 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K244041 - Jie Yang
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K244041 - Jie Yang
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assistance/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,

Amber T. Ballard -S

Amber Ballard, PhD
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120

Expiration Date: 07/31/2026

See PRA Statement below.

Submission Number (if known)

K244041

Device Name

Ultrasound Therapy Workstation (XMS-UET2)

Indications for Use (Describe)

This device is intended for use only in adult patients.

Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1) Pain relief, muscle spasms and joint contractures.
2) Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
3) Relief of sub-chronic, chronic pain and joint contractures resulting from:
- Capsular tightness
- Capsular scarring

For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:

1) Symptomatic relief of chronic intractable pain
2) Post-traumatic acute pain
3) Post-surgical acute pain

Additionally for NMS, NMS Burst, Hi-Volt and Russian:

1) Relaxation of Muscle spasms
2) Prevention or retardation of disuse atrophy
3) Increasing local blood circulation
4) Muscle re-education
5) Maintaining or increasing range of motion
6) Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For DC Continuous Mode

1) Relaxation of muscle spasm

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.

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2025-10-07

1. Submission sponsor

Name: Xemis Medical Technology (Shenzhen) Co., Ltd.
Address: 1101/1102/1201/1202, Unit 1, Building 2, Hongpeng Building, Tiegang Community, Xixiang Street, Baoan, Shenzhen, China
Contact person: Yang Yongfen
Title: RA Engineer
E-mail: [e-mail]
Tel: [phone]

2. Submission correspondent

Name: Chonconn Consulting Co., Ltd.
Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China
Contact person: Yang Jie
E-mail: [e-mail]
Tel: [phone]

3. Subject Device Information

| Trade/Device Name | Ultrasound Therapy Workstation |
| --- | --- |
| Model | XMS-UET2 |
| Common Name | Ultrasound Therapy Workstation |
| Regulatory Class | Class II |
| Classification Regulation | 21 CFR 890.5860 (Ultrasound and muscle stimulator) |
| Product codes | IMG, IPF, GZI, GZJ, LIH |
| Submission type | Traditional 510(K) |

4. Predicate Device

| | Device name and model | K number | Manufacturer |
| --- | --- | --- | --- |
| Predicate device | ComboRehab | K150436 | Shenzhen Dongdixin Technology Co. Ltd. |

5. Device Description

The Ultrasound Therapy Workstation (model: XMS-UET2) is an AC-powered device designed to use electrical stimulation and therapeutic ultrasound. Key features include ultrasound output and electrical stimulation output. This device is intended for use in healthcare environments such as hospitals, rehabilitation centers, community health service centers, and clinics.

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The device has a color touchscreen display and a control knob with light ring. The screen display shows system information to the user. Both display screen and control knob can assist the user in selecting or adjusting parameters. All controls and indicators are controlled by software.

Three non-invasive therapeutic methods are available: electrotherapy, ultrasound therapy and combination therapy (ultrasound plus electrical stimulation). For each method, the device is configured with protocols and manual operation, which can facilitate users to choose pre-set protocols or adjust parameters to suit individual needs.

## 6. Indication for use

This device is intended for use only in adult patients.

## Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:

1) Pain relief, muscle spasms and joint contractures.
2) Relief of pain, muscle spasms and joint contractures that may be associated with:
- Adhesive capsulitis
- Bursitis with slight calcification
- Myositis
- Soft tissue injuries
- Shortened tendons due to past injuries and scar tissues
3) Relief of sub-chronic, chronic pain and joint contractures resulting from:
- Capsular tightness
- Capsular scarring

## For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:

1) Symptomatic relief of chronic intractable pain
2) Post-traumatic acute pain
3) Post-surgical acute pain

## Additionally for NMS, NMS Burst, Hi-Volt and Russian:

1) Relaxation of Muscle spasms
2) Prevention or retardation of disuse atrophy
3) Increasing local blood circulation
4) Muscle re-education
5) Maintaining or increasing range of motion
6) Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

## For DC Continuous Mode

1) Relaxation of muscle spasm

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7. Comparison to the Predicate Device

| Features | Subject Device: | Predicate Device | Comparison |
| --- | --- | --- | --- |
| 1.510(k) number | K244041 | K150436 | / |
| 2.Device name, Model | Ultrasound Therapy Workstation XMS-UET2 | ComboRehab | / |
| 3.Manufacturer | Xemis Medical Technology (Shenzhen) Co., Ltd. | Shenzhen Dongdixin Technology Co. Ltd | / |
| Product Code | IMG,GZI,GZJ,IPF,LIH | IMG, IPF, GZJ, GZI, LIH, HCC | Same, See indications for use. |
| Regulation Number | 21 CFR 890.5860 | 21 CFR 890.5860 | Same |
| Classification | Class II | Class II | Same |
| Type of use | Prescription | Prescription | Same |
| Indications for Use | This device is intended for use only in adult patients Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1) Pain relief, muscle spasms and joint contractures. 2) Relief of pain, muscle spasms and joint contractures that may be associated with: - Adhesive capsulitis - Bursitis with slight calcification - Myositis - Soft tissue injuries - Shortened tendons due to past injuries and scar tissues 3) Relief of sub-chronic, chronic pain and joint contractures resulting from: | Therapeutic Ultrasound Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: 1. Pain relief, muscle spasms and joint contractures. 2. Relief of pain, muscle spasms and joint contractures that may be associated with: • Adhesive capsulitis • Bursitis with slight calcification • Myositis • Soft tissue injuries • Shortened tendons due to past injuries and scar tissues 3. Relief of sub-chronic, chronic pain and joint contractures resulting from: • Capsular tightness • Capsular scarring For TENS, Interferential, | Same, The indications of the predicate device cover the subject device. The subject device does not have EMG and EMG triggered Stim indications compared with predicate. |

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| | - Capsular tightness
- Capsular scarring
For TENS, Interferential, premodulated (IFC), NMS and Microcurrent:
1) Symptomatic relief of chronic intractable pain
2) Post-traumatic acute pain
3) Post-surgical acute pain
Additionally for NMS, NMS Burst, Hi-Volt and Russian:
1) Relaxation of Muscle spasms
2) Prevention or retardation of disuse atrophy
3) Increasing local blood circulation
4) Muscle re-education
5) Maintaining or increasing range of motion
6) Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For DC Continuous Mode
1) Relaxation of muscle spasm | premodulated(IFC), NMS and Microcurrent:
1. Symptomatic relief of chronic intractable pain
2. Post-traumatic acute pain
3. Post-surgical acute pain
Additionally for NMS, NMS Burst, Hi-Volt and Russian:
1. Relaxation of Muscle spasms
2. Prevention or retardation of disuse atrophy
3. Increasing local blood circulation
4. Muscle re-education
5. Maintaining or increasing range of motion
6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For DC Continuous Mode
Relaxation of muscle spasm
For EMG
To determine the activation timing of muscles for:
1. Retaining of muscle activation
2. Coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
1. Relaxation muscle training
2. Muscle re-education
For EMG triggered Stim
1. Stroke rehab by muscle re-education
2. Relaxation of muscle spasms
3. Prevention or retardation of disuse atrophy
4. Increase local blood circulation
5. Muscle re-education |
| --- | --- | --- |

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| | | 6. Maintaining or increasing range of motion | |
| --- | --- | --- | --- |
| Electrotherapy Module | | | |
| Electrotherapy mode | NMS (Pulsed mode, burst mode)
TENS(Symmetrical, Asymmetrical, Alternating, Symmetrical Burst, Asymmetrical Burst, Alternating Burst, Symmetrical RAAS, Asymmetrical RAAS)
high volt
Russian
interferential (4-pole), premodulated (2-pole interferential), Microcurrent
Continuous DC | NMS (Pulsed mode, burst mode)
TENS(Symmetrical, Asymmetrical, Alternating, Symmetrical Burst, Asymmetrical Burst, Alternating Burst)
high volt
interferential (4-pole), premodulated (2-pole interferential),
Russian, Microcurrent
Direct current | Similar |
| EMG (Biofeedback) | no | yes | Different,
See indications for use. |
| Basic unit Characteristics | | | |
| 4. Power Source(s) | AC line | AC line | Same |
| -Method of Line Current Isolation | Transformer | Transformer | Same |
| -Leakage current
– Normal condition
- Single fault condition | 75 μA
130 μA | d.c:0. a.c.:76.5
d.c:0. a.c.:132.1 | Same |
| 5. Number of output modes | 10 | 10 | Same |
| 6. Number of output channel | 6 | 4 | Similar |
| - Synchronous | 1&2 or 3&4 or 5&6 | 1 &2 or 3&4 | Similar |
<br>
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| or Alternation? | | | |
| --- | --- | --- | --- |
| -Method of Channel Isolation | Through transformers and isolators | Not publicly available | Similar |
| 7.Regulated Current or Regulated Voltage? | Optional
Optional | Optional
Optional | Same |
| 8. Software/Firmware/Microprocessors or control? | Yes | Yes | Same |
| 9. Automatic Overload trip | Yes | Yes | Same |
| 10. Automatic no-load trip | Yes | Yes | Same |
| 11. Automatic Shut Off | Yes | Yes | Same |
| 12. Patient override control method | Yes | Yes
Patient interrupt switch | Same |
| 13. Indicator display
-On/Off status
-Low battery
-Voltage/Current Level? | Yes
N/A
Yes | Yes
Yes
Yes | Same |
| 14. Timer range (minutes) | 0-60 minutes | 0-60 minutes | Same |
| 15.Compliance with voluntary standards | ISO 14971,
IEC 60601-1;
IEC 60601-1-2;
IEC 60601-2-5; | ISO14971,
IEC 60601-1,
60601-1-2,
IEC 60601-2-10, | Same |

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| | IEC 60601-2-10 | IEC60601-2-5, MDD 93/42/EEC,Annex II | |
| --- | --- | --- | --- |
| 16. Compliance with 21CFR 898 | Yes | Yes | Same |
| 17. Weight(lbs.) | 9.48 | 10.36 | Similar |
| 18. Dimensions (in.) H*W * L | 9.5in*7.5in*16.2 in | 10 x 7x15.5 | Similar |
| 19. Housing material and construction | Plastic | Plastic | Same |
| Output specifications | | | |
| Waveform | NMS (Pulsed mode, burst mode): Biphasic TENS: Biphasic high volt: Monophasic Russian: Biphasic interferential (4-pole): Biphasic premodulated (2-pole interferential): Biphasic Microcurrent: Monophasic Continuous DC: DC | NMS (Pulsed mode, burst mode): Biphasic TENS: Biphasic high volt: Monophasic Russian: Biphasic interferential (4-pole): Biphasic premodulated (2-pole interferential): Biphasic Microcurrent: Monophasic Continuous DC: DC | Same |
| Shape | NMS (Pulsed mode, burst mode): Square TENS: Square high volt: Twin spike Russian: Sinusidal interferential (4-pole): Sinusidal premodulated (2-pole interferential): Sinusidal Microcurrent: Square Continuous DC:DC | NMS (Pulsed mode, burst mode): Square TENS: Square high volt: Twin spike Russian: Sinusidal interferential (4-pole): Sinusidal premodulated (2-pole interferential): Sinusidal Microcurrent: Square Continuous DC:DC | Same |
| Maximum output voltage(V)± 20% | NMS (Pulsed mode, burst mode): 100@500Ω TENS: 100@500Ω | Not publicly available | different for i.NMS mode at 2k Ω |

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| | high volt: 462@500 Ω
Russian: 50.2@500Ω
interferential (4-pole): 50.2@500Ω
premodulated (2-pole interferential): 50.3@500Ω
Microcurrent: 0.5@500Ω
Continuous DC: 38@500Ω
NMS (Pulsed mode, burst mode): 220@2KΩ
TENS: 220@2KΩ
high volt: 487@2KΩ
Russian: 202@2KΩ
interferential (4-pole): 202@2KΩ
premodulated (2-pole interferential): 202@2KΩ
Microcurrent: 2.2@2KΩ
Continuous DC: 150@2KΩ
Microcurrent: 11@10k Ω
high volt: 487@10KΩ
NMS, TENS, high volt, Russian, interferential (4-pole), premodulated (2-pole interferential) and Continuous DC are unable to output@10kΩ, indicating no load | | ii.Russian mode at 2k Ω
iii.Inferential mode at 2k Ω
iv.Premodulated mode at 2k Ω
v.Continuous DC mode at 2k Ω |
| --- | --- | --- | --- |
| Maximum output current(mA) ±20% | NMS (Pulsed mode, burst mode): 200@500Ω
TENS: 200@500Ω
Russian: 100.4@500Ω
interferential (4-pole): 100.4@500Ω
premodulated (2-pole interferential): 100.6@500Ω
Microcurrent: 1@500Ω
Continuous DC: 76@500Ω
high volt: 927@500 Ω | Not publicly available | Different for
i.Continuous DC mode at 500 Ω
ii.Russian mode at 2k Ω
iii.Inferential mode at 2k Ω |

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| | NMS (Pulsed mode, burst mode): 110@2KΩ
TENS: 110@2KΩ
Russian: 101@2KΩ
interferential (4-pole): 101@2KΩ
premodulated (2-pole
interferential): 101@2KΩ
Microcurrent: 1.1@2KΩ
Continuous DC: 75@2KΩ
high volt: 243.5@2k Ω

high volt: 48.7@10k Ω
Microcurrent: 1.1@10k Ω

NMS, TENS, Russian, interferential (4-pole), premodulated (2-pole
interferential) and Continuous DC are unable to output@10kΩ, indicating no load | | iv.Premodulated mode at 2k Ω
v.Continuous DC mode at 2k Ω |
| --- | --- | --- | --- |
| Pulse Width | NMS (Pulsed mode, burst mode): 20~400μs
TENS: 20~1000μs
high volt: 10μs
Russian: 50~250μs
interferential (4-pole): 50~250μs
premodulated (2-pole
interferential): 50~250μs
Microcurrent: 0.5ms~5s | Not publicly available | Different |
| Frequency(H z) | NMS (Pulsed mode, burst mode): 1~250Hz
TENS: 1~250Hz
high volt: 1~120Hz
Russian: 2k~10kHz
interferential (4-pole): 2k~10kHz
premodulated (2-pole
interferential): 2k~10kHz
Microcurrent: 0.1~1000Hz
Continuous DC: N/A | NMS (Pulsed mode, burst mode): 1~250Hz
TENS: 1~250Hz
high volt:1~120Hz
Russian: Not publicly available
interferential (4-pole):2k~10kHz
premodulated (2-pole
interferential): 2k~10kHz
Microcurrent: 0.1~1000Hz
Continuous DC: N/A | Different for Russian mode |

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| For interferential modes only: - Beat Frequency(H z) | Interferential, 4-pole: 1-200Hz Interferential, 2-pole, Premodulated: 1-150Hz | Interferential, 4-pole:1-200Hz Interferential, 2-pole, Premodulated: 1-200Hz | Similar |
| --- | --- | --- | --- |
| For multiphasic waveforms only: - Symmetrical phases? | NMS (Pulsed mode, burst mode): Yes TENS: Yes high volt: No Russian: Yes interferential (4-pole): Yes premodulated (2-pole interferential): Yes Microcurrent: No | NMS (Pulsed mode, burst mode): Yes TENS: Yes high volt: No Russian: Yes interferential (4-pole): Yes premodulated (2-pole interferential): Yes Microcurrent: No | Same |
| - Phase Duration (include units) (state range, if applicable) (both phases, if asymmetrical) | NMS (Pulsed mode, burst mode): 20~400μs TENS: 20~1000μs high volt: 100μs Russian: 50~250μs interferential (4-pole): 50~250μs premodulated (2-pole interferential): 50~250μs Microcurrent: 0.5ms~5s Continuous DC:N/A | NMS (Pulsed mode, burst mode): 20us-1000us TENS: 20~1000μs high volt:100μs Russian: Not publicly available interferential (4-pole):Not publicly available premodulated (2-pole interferential): Not publicly available Microcurrent: Not publicly available Continuous DC: N/A | Similar |
| Net Charge (per pulse) | CC mode: Microcurrent: 5000μC @500Ω CV mode: high volt: 5μC @500Ω The rest: Zero | Not publicly available | Different for Microcurrent mode |
| Symmetry | Symmetric and asymmetric | Symmetric and asymmetric | Same |
| Method | Balanced | Not publicly available | Same |
| Maximum Phase Charge(μC)(500Ω) | NMS (Pulsed mode, burst mode): 60 TENS: 100 high volt:5 Russian:15.92 interferential (4-pole): 15.92 premodulated (2-pole | Not publicly available | Different for Microcurrent mode |

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{15}

| | interferential): 15.92
Microcurrent: 5000 | | |
| --- | --- | --- | --- |
| Maximum current density(mA/cm²,500Ω) | NMS (Pulsed mode, burst mode): 1.8,0.9
TENS: 2.0,1.4,1.5,1.1
high volt: 0.92
Russian:2.0
interferential (4-pole): 2.8
premodulated (2-pole interferential): 2.0
Microcurrent: 0.028
Continuous DC: 3.2 | Not publicly available | Different for i.Russian mode
ii.Microcurrent mode |
| Maximum power density (W/cm²,500 Ω) | NMS (Pulsed mode, burst mode): 0.04,0.01
TENS:0.049,0.025,0.030,0.015
high volt: 0.01
Russian:0.050
interferential (4-pole): 0.101
premodulated (2-pole interferential): 0.050
Microcurrent: 0.00001
Continuous DC:0.128 | Not publicly available | Different for i.NMS mode
ii.TENS mode
iii.High volt mode
iv.Russian mode |
| Burst Mode
a. Pulses per burst | NMS (Pulsed mode): N/A
NMS (burst mode): 7
TENS: 7
high volt: N/A
Russian: N/A
interferential (4-pole): N/A
premodulated (2-pole interferential): N/A
Microcurrent: N/A
Continuous DC:N/A | Not publicly available | Same |
| b. Bursts per second | NMS (Pulsed mode): N/A
NMS (burst mode): 1~9
TENS: 1~9
high volt: N/A
Russian: 20~100
interferential (4-pole): N/A
premodulated (2-pole interferential): N/A
Microcurrent: N/A | Not publicly available | Same |

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{16}

| | Continuous DC:N/A | | |
| --- | --- | --- | --- |
| c. Burst duration (ms) | NMS (Pulsed mode): N/A NMS (burst mode): 28~984 ms TENS: 28~984 ms high volt: N/A Russian: 2~25 ms interferential (4-pole): N/A premodulated (2-pole interferential): N/A Microcurrent: N/A Continuous DC:N/A | Not publicly available | Same |
| d. Duty Cycle [Line (b) x Line (c)] | NMS (Pulsed mode): N/A NMS (burst mode): 2.8%~98.4% TENS: 2.8%~98.4% high volt: N/A Russian: 10%~50% interferential (4-pole): N/A premodulated (2-pole interferential): N/A Microcurrent: N/A Continuous DC:N/A | Not publicly available | Same |
| ON Time (seconds) | NMS (Pulsed mode): 0~60s TENS(not include burst mode): 0~60s high volt: 0~60s Russian:0~60s interferential (4-pole): N/A premodulated (2-pole interferential): 0~60s Microcurrent: 0~60s Continuous DC:N/A | NMS (Pulsed mode): 0~60s TENS(not include burst mode): 0~60s high volt: 0~60s Russian: 0~60s interferential (4-pole): N/A premodulated (2-pole interferential): 0~60s Microcurrent: 0~60s Continuous DC:N/A | Same |
| OFF Time (seconds) | NMS (Pulsed mode): 0~60s TENS(not include burst mode): 0~60s high volt: 0~60s Russian:0~60s interferential (4-pole): N/A premodulated (2-pole interferential): 0~60s Microcurrent: 0~60s Continuous DC:N/A | NMS (Pulsed mode): 0~60s TENS(not include burst mode): 0~60s high volt: 0~60s Russian: 0~60s interferential (4-pole): N/A premodulated (2-pole interferential): 0~60s Microcurrent: 0~60s Continuous DC:N/A | Same |

{17}

| Ultrasound Module | | | |
| --- | --- | --- | --- |
| Power Source | AC line | AC line | Same |
| Maximum Treatment Time: | 30 minutes | 30 minutes | Same |
| Frequency | 1 MHz or 3 MHz | 1 MHz or 3 MHz | Same |
| Modes | Continuous and Pulsed | Continuous and Pulsed | Same |
| Pulse Repetition Rate | 100Hz, 48Hz, 16Hz | 16Hz, 48Hz, 100Hz | Same |
| Pulse Duration | 1.0ms~56.3ms (±5%) | Not publicly available | Different |
| Temporal Peak/average intensity ration | 1~10 (±5%) | 1~10 | Same |
| Maximum intensity | 2 W/cm2for continuous mode3 W/cm2for pulsed mode | 3 W/cm2 | Same |
| Indication accuracy | ±20 % | ±20 % | Same |
| Piezoelectric discs | Ultrasound transducer attached to a metal surface and patient contact through the metal | Ultrasound transducer attached to a metal surface and patient contact through the metal | Same |
| Frequency | 1 MHz or 3 MHz | 1 MHz or 3 MHz | Same |
| Effective radiating area | A9050: 4cm2A8040: 4cm2A3010: 1cm2 | 5 cm21 cm2 | Similar |
| Maximum beam non-uniformity ratio | 5:1 maximum | 5:1 maximum | Same |
| Beam type | collimated | collimated | Same |
| Applicator material | AL6061 | Not publicly available | Similar |
| Crystal Material | piezocrystal | piezocrystal | Same |
| Temporal Max Power (W) for | A3010 (1cm2): 3W±20%A8040 (3cm2): 9W±20%A9050 (4cm2): 12W±20% | 1cm2: 2W±20%5cm2: 15W±20% | Similar |
| Maximum Time | 100s | 100s | Same |

{18}

| pulsed mode | | | |
| --- | --- | --- | --- |
| Temporal Average Power (W) for continuous mode | A3010 (1cm2): 2W±20%A8040 (3cm2): 6W±20%A9050 (4cm2): 8W±20% | Not publicly available | Similar |
| Instantaneous Peak Power (W) | A3010 (1cm2): 3W±20%A8040 (3cm2): 9W±20%A9050 (4cm2): 12W±20% | 1cm2: 2W±20%5cm2: 15W±20% | Similar |
| Temporal Max Effective Intensity (W/cm2), peak P/ERA | 3W/cm2 | 3 W/cm2±20 % | Same |
| Temporal Average Intensity(W/cm2) | 0~2.1W/cm2, ±20% | Not publicly available | Similar |
| Temporal Peak to Average Ratio (Rtpa) for pulsed mode | 10.00:1 ±5 % at 10 % Duty Cycle5.00:1 ±5 % at 20 % Duty Cycle3.33:1 ±5 % at 30 % Duty Cycle2.50:1 ±5 % at 40 % Duty Cycle2.00:1 ±5 % at 50 % Duty Cycle1.67:1 ±5 % at 60 % Duty Cycle1.43:1 ±5 % at 70 % Duty Cycle1.25:1 ±5 % at 80 % Duty Cycle1.11:1 ±5 % at 90 % Duty Cycle | 10.00:1 ±5 % at 10 % Duty Cycle5.00:1 ±5 % at 20 % Duty Cycle3.33:1 ±5 % at 30 % Duty Cycle2.50:1 ±5 % at 40 % Duty Cycle2.00:1 ±5 % at 50 % Duty Cycle1.67:1 ±5 % at 60 % Duty Cycle1.43:1 ±5 % at 70 % Duty Cycle1.25:1 ±5 % at 80 % Duty Cycle1.11:1 ±5 % at 90 % Duty Cycle | Similar |
| Error uncertainties for the ultrasonic frequency | ±10% | ±10% | Same |

{19}

There are differences in output parameters between the subject and predicate devices. First, the subject device has additional TENS output modes (i.e., Symmetrical RAAS, Asymmetrical RAAS). These output modes do not raise new questions of safety and effectiveness nor a new intended use.

There are minor differences in maximum output voltage, maximum output current, frequency, and phase duration which do not raise new questions of safety and effectiveness.

The net charge and phase charge for the Microcurrent mode are very large which could increase the risk of skin irritation and burns. Additionally, the device is capable of delivery current densities greater than $2\mathrm{mA/cm^2}$ (i.e., the limit set by IEC 60601-2-10). However, this risk associated with these parameters has been mitigated with labeling revisions which 1) warn users of the risk of skin irritation and burns, 2) instruct device operators to monitor patients for adverse events throughout the duration of treatment, and 3) instruct that the treatment site should be examined after each treatment session to monitor for signs of irritation and/or burns.

Minor differences in the power density do not raise questions of safety and effectiveness since they remain under the $0.25\mathrm{W/cm^2}$ limit set within the FDA guidance document "Guidance Document for Powered Muscle Stimulator 510(k)s."

Lastly, there are minor differences in the ultrasound output parameters which do not raise new questions of safety and effectiveness.

## 8. Non-clinical tests

The following performance data were provided in support of the substantial equivalence determination.

## Biocompatibility testing

Biocompatibility of the subject device was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.

## Electrical safety, electromagnetic compatibility (EMC) and performance

Electrical safety, EMC and performance testing were performed to, and passed, the following standards:

- ANSI AAMI ES60601-1 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 compatibility Requirements and tests
- IEC 60601-2-5 Particular requirements for the basic safety and essential

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performance of ultrasonic physiotherapy equipment

- IEC 60601-2-10 Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

9. Clinical study

Not applicable.

10. Conclusion

Substantial equivalence comparisons, performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.

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