(439 days)
Not Found
No
The document does not mention the terms "AI", "DNN", or "ML", nor does it describe any functionality or components that would typically involve an AI model, such as image processing for diagnostic purposes or complex data analysis for treatment guidance beyond basic device alerts. The device's function is purely therapeutic ultrasound application.
Yes
The 'Intended Use / Indications for Use' section explicitly states the device is for "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," which are therapeutic applications.
No
Explanation: The device is described as applying ultrasound to generate deep heat for treatment of various medical conditions, such as pain relief, muscle spasms, and joint contractures. Its intended use focuses on therapy rather than diagnosis.
No
The device description explicitly lists several hardware components, including the main device, applicator, charger/adapter, and ultrasound gel, all of which are essential for its function of applying ultrasound. The summary also details extensive non-clinical tests related to electrical safety, electromagnetic compatibility, and performance of physical components, clearly indicating it is a hardware-based medical device with integrated software.
No
The device uses ultrasound to generate deep heat for therapeutic purposes, such as pain relief and muscle spasm treatment. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
IMI, PFW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home or clinical/hospital setting by or under the direction of a medical professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical 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. All the non-clinical tests performed above demonstrate the subject device is as safe and as effective as the legally marketed predicate devices.
The tests performed include:
- 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
- Software evaluation
Clinical testing was not provided in support of this 510(k) application.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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-
Page 3
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:
Department of Health and Human Services
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PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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
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.
Page 1 of 6
Page 6
Page 2 of 6
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 |
Page 7
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 |
Page 8
Page 4 of 6
| 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 |