Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

Pain.
Pain relief, muscle spasms, and joint contractures.
Relief of pain, muscle spasms, and joint contractures that may be associated with:
- Adhesive capsulitis,
- Bursitis with slight calcification,
- Myositis,
- Soft tissue injuries, and
- Shortened tendons due to past injuries and scar tissues.
Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and
- Capsular scarring.
Localized increase in blood flow.
Increased range of motion of contracted joint using heat and stretch techniques.

Device Description

As a portable and rechargeable prescriptive device in the home or clinical/hospital setting, the subject device is intended to apply ultrasound to the patient's treatment site. It is demonstrated ultrasound can be used to apply therapeutic deep heat for the treatment of medical conditions including relief of pain, muscle spasms, and joint contractures.

It is intended to be used for 30 minutes per cycle (up to 4 cycles) in the home or clinical/hospital setting by or under the direction of a medical professional to apply ultrasound to the patient's treatment site. The device automatically alerts the patient in case of improper application or performance. All the control components and the rechargeable battery of the device are protectively housed, and the device is connected to one or two applicators of ultrasound.

The subject device consists of the main device, the applicator, the charger/adapter, the liquid and/or solid ultrasound gel, and the sticky pad. For the best result, use the ultrasound gel and the sticky pad supplied.

AI/ML Overview

This looks like a fascinating case study. Based on the provided FDA 510(k) clearance letter and summary, here's an analysis of the acceptance criteria and the study that proves the device meets them.

It's important to note that this document is for an Ultrasound Stimulator (Ultrasonic Diathermy), which delivers therapeutic ultrasound, not an AI/Software as a Medical Device (SaMD) that typically involves image analysis or diagnostic support. Therefore, many of the typical acceptance criteria and study designs related to diagnostic accuracy, MRMC studies, and nuanced ground truth establishment for AI models (as implied by the original request's detailed points) are not applicable to this type of physical therapy device.

The "acceptance criteria" here are primarily based on demonstrating substantial equivalence to predicate devices through engineering specifications, performance testing, and safety profiles, rather than clinical efficacy studies in the way an AI diagnostic tool would require.

Acceptance Criteria and Study Proving Device Meets Criteria

Given that the device is an Ultrasound Stimulator aiming for 510(k) clearance based on substantial equivalence, the "acceptance criteria" are not framed in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) but rather in terms of demonstrating that its technical characteristics, performance, and safety are equivalent to legally marketed predicate devices. The "study" proving it meets these criteria is a comprehensive set of non-clinical, bench performance tests and comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

For an Ultrasound Stimulator, the "acceptance criteria" are primarily a demonstration of equivalence to the predicate devices across various technical and functional parameters, and compliance with relevant safety standards. The "reported device performance" are the results of the non-clinical tests and direct comparisons to the predicate devices.

Parameter/Acceptance Criteria Category	Specific Acceptance Criteria (Demonstrated Equivalence/Compliance)	Reported Device Performance (Subject Device)
Intended Use	Identical or substantially equivalent indications to predicate device.	Apply stationary/continuous ultrasound for deep heat, pain relief, muscle spasms, joint contractures, increased circulation, range of motion (identical to primary predicate, similar to other predicate).
Product Code	Identical to predicate device.	IMI, PFW (Identical to predicate ManaSport+, and PFW to sam 2.0)
Prescription Status	Identical (Prescription Use).	Prescription Use (Identical).
Power Source	Similar, safe power delivery.	100~240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery (Identical to primary predicate, similar to other predicate).
Number of Outputs	1 or 2 outputs.	1 or 2 (Identical to sam 2.0, similar to ManaSport+ which is 1).
Software/Microprocessor Control	Presence and safe operation.	Yes (Identical).
Safety Features	Automatic No-Load Trip, Automatic Shut Off, User Override Control, Indicator Display (On/Off, Low Battery).	All 'Yes' for these features (Identical where predicate information available).
Timer Range	Functionally acceptable and safe timer range.	30 minutes (per cycle), max 4 cycles (Longer than primary predicate (20min), shorter than predicate (240min), deemed safe by temperature control).
Compliance with Voluntary Standards	Compliance with relevant IEC/ISO electrical safety, EM compatibility, and biocompatibility standards.	Yes (Complies with ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-5, ISO 10993-5, ISO 10993-10, IEC 60601-1-6, IEC 60601-1-11).
Biocompatibility	Non-toxic, non-irritating materials.	Yes (Identical).
Sterility	Non-sterile device.	Non-Sterile (Identical).
Housing Construction Material	Compatible material.	ABS (Identical).
Physical Dimensions/Weight	Similar physical characteristics not affecting safety/effectiveness.	Console/Generator: 138×62×22 mm, 0.18 kg (Similar to predicates). Treatment Head: 61 x 45 x 12 mm, 0.047 kg (Similar to predicates).
Functions and Design	Ultrasound generation.	Ultrasound (Identical).
Frequency	1.5 MHz or similar.	1.5 MHz ± 10% (Identical to primary predicate, similar to other predicate's 3MHz).
Leakage Current	Below maximum limit.	<0.3mA (Identical).
Crystal Material	PZT or similar.	PZT (Identical).
Technology of Ultrasound Generation	Piezoelectric.	Piezoelectric (Identical).
Output Mode	Continuous Wave - 100% duty cycle.	Continuous Wave - 100% duty cycle (Identical).
Power (Output, Temporal Avg., Effective Intensity, Beam Max Intensity)	Within specified ranges and tolerances, consistent with therapeutic effect and safety.	Max Output Power: 0.60 W ± 20% (Similar to predicates). Temporal Average Power: 0.60 W ± 20% (Identical where available). Max Effective Intensity: 0.15 ± 20% (Identical or similar to predicates, within IEC deviation). Beam Max Intensity: 0.15 ± 20% (Identical or similar to predicates, within IEC deviation).
Duty Factor	100%.	100% (Identical).
Beam Type	Collimated or Divergent.	Collimated (Note: Predicate sam 2.0 is Divergent, but both are acceptable).
Applicator Size	Equivalent treatment area.	Area: 3.9 cm² (Identical to primary predicate, similar to other predicate).
Maximum Patient Contact Surface Temperature	Meets safety standards (e.g., IEC 60601-2-5, section 201.11).	Meets IEC 60601-2-5, section 201.11, with an enforced overheating temperature protection to prevent exceeding 43°C. (Identical or safer than predicate 44°C).
Peak Temperature Rise vs. Time and Tissue Depth	Demonstrated safe heating profile over maximum treatment time.	8.6°C at 1 cm, 6.1°C at 2 cm, 2.1°C at 3 cm (Max treatment time: 30 min per cycle, 4 cycles). Deemed safe due to 43°C cap. (Similar to predicates' reported temperature rises).
Beam Non-Uniformity Ratio (BNR)	<5:1 or similar.	<5 (Identical or similar to predicates).
Effective Radiating Area (ERA)	3.9 cm² or similar.	3.9 ± 20% (Identical to primary predicate, similar to other predicate).
Software Verification	Carried out according to FDA guidance.	Verification carried out according to FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Bench Performance Testing	Successful completion as per established protocols.	Evaluation of power output, total treatment time, electrical safety, EMC, device operation, usability, biocompatibility, thermal safety.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: This is a physical device (Ultrasound Stimulator), not a diagnostic AI. Therefore, the concept of a "test set" in the context of a dataset for an AI model (like images or patient records) does not apply. The "test set" would be the number of devices/units subjected to engineering and performance verification tests. This information is typically not specified in a 510(k) summary; manufacturers test a representative number of units to ensure compliance with standards.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): This is not applicable to a physical therapy device like an ultrasound stimulator. The "data" refers to engineering measurements and test results, not patient data. The device is manufactured by JKH Health Co., Ltd. in China, and presumably, the non-clinical tests were conducted at their facilities or accredited test labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. For a device like an Ultrasound Stimulator, there is no "ground truth" to be established by experts in the sense of image interpretation for diagnosis. The "ground truth" for performance is based on defined engineering parameters, physical measurements, and compliance with international standards (e.g., IEC, ISO). These are verified by qualified test engineers and technicians using calibrated equipment, not by clinical experts like radiologists.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus "ground truth." This device does not involve human interpretation as part of its function or testing for 510(k) clearance. Compliance is determined by objective measurements against predefined specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for evaluating diagnostic AI systems (or human performance with and without AI assistance) where human perception and interpretation are key. An Ultrasound Stimulator is a therapeutic device, not a diagnostic one, and its 510(k) clearance path relies on demonstrating substantial equivalence in engineering, performance, and safety, not on improving human diagnostic accuracy.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable in the traditional sense of AI algorithm performance. This is an Ultrasound Stimulator, a physical device. It has software, but the "performance" tested is its ability to generate ultrasound at specific parameters and safely, not to process data or make diagnostic outputs. Its core function is a physical treatment delivery, verified through bench testing, not an "algorithm-only" diagnostic output. The software verification mentioned (according to FDA Guidance for Software Contained in Medical Devices) ensures the software itself is designed, developed, and tested appropriately, but this isn't analogous to testing the diagnostic performance of an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Engineering Specifications and International Standards: The "ground truth" for this device is its adherence to predefined engineering specifications and compliance with established international safety and performance standards (e.g., IEC 60601 series, ISO 10993 series). These are objective, measurable criteria. For instance, ground truth for power output is a specific wattage with an allowed tolerance, measured by calibrated equipment, not a clinical diagnosis.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI model that requires a "training set" of data for machine learning.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set for an AI model, the question of establishing its ground truth does not apply.

In summary: The provided document is for a Class II Ultrasound Stimulator, a therapeutic device. Its premarket clearance (510(k)) is based on demonstrating substantial equivalence to predicate devices, primarily through comprehensive non-clinical bench testing to verify performance parameters, electrical safety, electromagnetic compatibility, biocompatibility, and thermal safety in accordance with recognized international standards. The evaluation process for such a device does not involve the AI-specific criteria (like test set data provenance, expert adjudication, MRMC studies, or training sets for AI models) that were part of the initial request, as those are typically relevant for diagnostic AI/SaMD submissions.

Summary

FDA 510(k) Clearance Letter - Ultrasound Stimulator

Page 1

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

Doc ID # 04017.07.05

June 4, 2025

JKH Health Co., Ltd.
℅ Bill Dai
Managing Member
Jkh Usa LLC
14271 Jeffrey Rd.
#246
Irvine, California 92620

Re: K240788
Trade/Device Name: Ultrasound Stimulator
Regulation Number: 21 CFR 890.5300
Regulation Name: Ultrasonic Diathermy
Regulatory Class: Class II
Product Code: IMI, PFW
Dated: May 5, 2025
Received: May 5, 2025

Dear Dr. Bill Dai:

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.

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K240788 - Bill Dai Page 2

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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K240788 - Bill Dai Page 3

assistance/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,

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Indications for Use

Submission Number (if known)
K240788

Device Name
Ultrasound Stimulator

Indications for Use (Describe)

Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

Pain.
Pain relief, muscle spasms, and joint contractures.
Relief of pain, muscle spasms, and joint contractures that may be associated with:
- Adhesive capsulitis,
- Bursitis with slight calcification,
- Myositis,
- Soft tissue injuries, and
- Shortened tendons due to past injuries and scar tissues.
Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and
- Capsular scarring.
Localized increase in blood flow.
Increased range of motion of contracted joint using heat and stretch techniques.

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.

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:

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Page 5

510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter's Information

Submitter: JKH Health Co., Ltd.
Address: 3-5F And 11F, Building 14, Tiangong Smart Valley Industrial Park, Fuhai Road, Xiagang Community, Chang'an Town, Dongguan, Guangdong, China
Contact Person: Pu Jiang
Tel: +86-755-27926589
Fax: +86-755-29970323
Email: sales@JKHhealth.com
Date of Preparation: June 4, 2025

2. Subject Device

Trade/Device Name: Ultrasound Stimulator
Common Name: Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Review Panel: Physical Medicine
Product Code: IMI, PFW
Regulation Number: 21 CFR 890.5300
Device Class: II
Use: Prescription

3. Predicate device

Primary Predicate Device: ManaSport+
510(k) Number: K222098
Clearance Date: March 8, 2023
Submitter: ManaMed, Inc.

Predicate Device: sam 2.0 Long Duration Ultrasound System
510(k) Number: K191568
Clearance Date: March 6, 2020
Submitter: ZetrOZ Systems, LLC

4. Description of Subject Device

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If you feel your skin is sensitive to the ultrasound gel and/or pad supplied, please contact your physician or use a different FDA-cleared ultrasound gel and/or pad.

5. Indications for Use

Apply stationary use of ultrasound to:
Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.

Apply continuous movement of ultrasound for:

Pain.
Pain relief, muscle spasms, and joint contractures.
Relief of pain, muscle spasms, and joint contractures that may be associated with:
- Adhesive capsulitis,
- Bursitis with slight calcification,
- Myositis,
- Soft tissue injuries, and
- Shortened tendons due to past injuries and scar tissues.
Relief of pain, muscle spasms, and joint contractures resulting from:
- Capsular tightness, and
- Capsular scarring.
Localized increase in blood flow.
Increased range of motion of contracted joint using heat and stretch techniques.

6. Substantial Equivalence

The following Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device.

Table 1. Comparison between the predicate device and the subject device

Parameter & Predicate Device(s)	Subject Device	Primary Predicate Device	Predicate Device	Equivalence
510(k)/PMA Number	K240788	K222098	K191568	N/A
Submitter /Manufacturer	JKH Health Co., Ltd.	ManaMed, Inc.	ZetrOZ Systems, LLC	N/A
Device Name/Model	Ultrasound Stimulator	ManaSport+	sam 2.0 Long Duration Ultrasound System	N/A
Product Code of Ultrasound	IMI, PFW	IMI, PFW	PFW	Identical
Indications for Use	Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures. 3. Relief of pain, muscle	Apply stationary use of ultrasound to: Generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation. Apply continuous movement of ultrasound for: 1. Pain. 2. Pain relief, muscle spasms, and joint contractures.	The sam 2.0 Long Duration Ultrasound Device is intended for home use to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions such as the relief of pain, the relief of muscle spasms, the treatment of joint contractures, and the local increase in circulation.	Identical

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Page 3 of 6

Parameter	Subject Device	Primary Predicate Device	Predicate Device	Equivalence
[Continued Indications]	spasms, and joint contractures that may be associated with: • Adhesive capsulitis, • Bursitis with slight calcification, • Myositis, • Soft tissue injuries, and • Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: • Capsular tightness, and • Capsular scarring. 5. Localized increase in blood flow. 6. Increased range of motion of contracted joint using heat and stretch techniques.	3. Relief of pain, muscle spasms, and joint contractures that may be associated with: • Adhesive capsulitis, • Bursitis with slight calcification, • Myositis, • Soft tissue injuries, and • Shortened tendons due to past injuries and scar tissues. 4. Relief of pain, muscle spasms, and joint contractures resulting from: • Capsular tightness, and • Capsular scarring. 5. Localized increase in blood flow. 6. Increased range of motion of contracted joint using heat and stretch techniques.
Prescription or OTC	Prescription	Prescription	Prescription	Identical
Power Source(s)	100~240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery	100~240 Vac with 5Vdc Input and rechargeable 3.7Vdc battery	120/240 VAC with 5V DC Input PowerJack and Lithium Battery Powered	Identical
Number of Output	1 or 2	1	1-2	Identical
Software /Firmware/ Microprocessor Control?	Yes	Yes	Yes	Identical
Automatic No-Load Trip?	Yes	Yes	Not Publicly Available	Identical
Automatic Shut Off?	Yes	Yes	Not Publicly Available	Identical
User Override Control?	Yes	Yes	Not Publicly Available	Identical
Indicator Display: On/Off Status?	Yes	Yes	Not Publicly Available	Identical
Low Battery?	Yes	Yes	Not Publicly Available	Identical
Timer Range (minutes)	30	20	240	Longer than the primary predicate, and shorter than the predicate. There is an overheating temperature protection enforced to prevent the temperature of the treatment head going over 43°C during the normal use, so the possible range of temperature is lower than 43°C. The tests provided shows this does not affect the safety or effectiveness.
Compliance with Voluntary Standards?	Yes	Yes	Yes	Identical
Biocompatibility?	Yes	Yes	Yes	Identical
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Identical
Housing construction material	ABS	ABS	ABS	Identical
Console/Generator Dimensions(mm) [L x W x H]	138×62×22	140×56×24	61×70.9×18.8	Similar, and do not affect the safety or effectiveness
Console/Generator Weight (kg)	0.18	0.13	0.01	Similar, and do not affect the safety or effectiveness

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Parameter	Subject Device	Primary Predicate Device	Predicate Device	Equivalence
Treatment head dimensions (mm) [L x W x H]	61 x 45 x 12	30 x 30 x 12	38.1 x 33 x 11.4	Similar, and do not affect the safety or effectiveness
Treatment Head Weight (kg)	0.047	0.031	0.10	Similar, and do not affect the safety or effectiveness
Functions and design	Ultrasound	Ultrasound	Ultrasound	Identical
Frequency	1.5 MHz ± 10%	1.5	3MHz ± 20%	Identical
Leakage current	<0.3mA	<0.3mA	0.3mA	Identical
Crystal material	PZT	PZT	Lead Zirconate-Titanate	Identical
Technology of Ultrasound generation	Piezoelectric	Piezoelectric	Piezoelectric	Identical
Output Mode	Continuous Wave - 100% duty cycle	Continuous Wave - 100% duty cycle	Continuous Wave - 100% duty cycle	Identical
Ratio of temporal maximum output power to the output power	1:1	1:1	Not Publicly Available	Identical
Maximum Value of the Output Power (W ± 20%)	0.60	0.60	Single Applicator: 0.65W ± 20% Dual Applicator: 1.3W ± 20%	Similar
Temporal average power (W ± 20%)	0.60	0.60	Not Publicly Available	Identical
Maximum value of the effective intensity (W/cm²)	0.15 ± 20%	0.16 ± 20%	0.264 ± 20%	Identical or similar. According to the IEC 61689, the deviation allowed is ± 30%.
Beam Maximum Intensity and Accuracy (W/cm²)	0.15 ± 20%	0.16 ± 20%	0.132 ± 20%	Identical or similar. According to the IEC 61689, the deviation allowed is ± 30%.
Duty factor	100%	100%	Not Publicly Available	Identical
Beam Type	Collimated	Collimated	Divergent	Identical
Applicator size	Area: 3.9 cm²	Area: 3.9 cm² or 5cm²	One Applicator: 5 cm² Two Applicators: 10 cm²	Identical
Maximum patient contact surface temperature of the treatment head under simulated or actual use conditions for all operating conditions (continually operated for maximum treatment time) (°C)	Meets IEC 60601-2-5, section 201.11 Protection against excessive temperature and other HAZARDS.	Meets IEC 60601-2-5, section 201.11 Protection against excessive temperature and other HAZARDS.	44 °C	Identical
Peak Temperature Rise vs. Time and Tissue Depth to Maximum Treatment Time (for fixed Treatment Head Placement) (°C)	8.6°C at 1 cm 6.1°C at 2 cm 2.1°C at 3 cm Max treatment time: 30 min per cycle and 4 cycles	7.6°C at 1 cm 3.3°C at 2 cm 1.4°C at 3 cm Max treatment time: 20 min	8°C at 1 cm 6°C at 3 cm 3°C at 5 cm Max treatment time: 4 hours	Identical or similar. There is an overheating temperature protection enforced to prevent the temperature of the treatment head going over 43°C during the normal use, so the possible range of temperature is lower than 43°C. The tests provided shows this does not affect the safety or effectiveness.
Beam Non-Uniformity Ratio	<5	4 ± 20%	<5:1 ± 20%	Identical
Effective Radiating Area (cm²)	3.9 ± 20%	3.9 or 5 ± 20%	One: 6 cm² Two:12 cm² ± 20%	Identical

7. Summary of Substantial Equivalence

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As shown in the above Table 1, the ultrasound from the subject device is identical or similar to the predicate device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, safety, and effectiveness to the predicate device.

8. Non-Clinical Tests Performed

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(a) ANSI AAMI ES60601-1 "Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1)".

(b) 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".

(c) IEC 60601-2-5 "Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment".

(d) ISO 10993-5 "Biological evaluation of medical devices -- Part 5: Tests for In Vitro Cytotoxicity".

(e) ISO 10993-10 "Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization".

(f) IEC 60601-1-6 "Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability".

(g) 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"

In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, and the bench performance testing for the subject device and ultrasonic gel pad has also been conducted.

The subject device was evaluated to ensure all the non-clinical tests in this submission support a determination of substantial equivalence, including:

Power output evaluation
Evaluation of total treatment time
Electrical safety and EMC evaluation
Device Operation evaluation
Powering On/Off
Usability evaluation
Biocompatibility evaluation
Thermal safety evaluation
Performance evaluation

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Software evaluation

All the non-clinical tests performed above demonstrate the subject device is as safe and as effective as the legally marketed predicate devices. The detailed comparison between the subject device and the predicate devices in the above Table 1 demonstrates the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate devices.

9. Clinical Testing

Clinical testing was not provided in support of this 510(k) application.

10. Conclusion

The testing and comparison performed demonstrate the subject device is substantially equivalent to the predicate devices. Therefore, the subject device is as safe and effective as the predicate devices that have been legally marketed in the United States.

Regulation Number and Section

§ 890.5300 Ultrasonic diathermy.

(a)
Ultrasonic diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. An ultrasonic diathermy 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.(2)
Classification. Class II (performance standards).(b)
Ultrasonic diathermy for all other uses —(1)Identification. An ultrasonic diathermy for all other uses except for the treatment of malignancies is a device that applies to the body ultrasonic energy at a frequency beyond 20 kilohertz and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP for a device described in paragraph (b) of this section is required to be filed with the Food and Drug Administration on or before July 13, 1999, for any ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976, or that has, on or before July 13, 1999, been found to be substantially equivalent to an ultrasonic diathermy described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasonic diathermy described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.