(302 days)
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Not Found
No
The provided 510(k) summary describes a therapeutic ultrasound and electrical stimulation device with standard indications for use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The lack of information on training/test sets and performance metrics further supports the absence of AI/ML.
Yes
The "Intended Use / Indications for Use" section explicitly states "Therapeutic Ultrasound" and lists various medical conditions it treats, such as pain relief, muscle spasms, and joint contractures. It also mentions "symptomatic relief of chronic intractable pain" and "relaxation of Muscle spasms" for other modalities, all of which are therapeutic applications.
No
This device is described as providing therapeutic treatments like pain relief, muscle relaxation, and increasing range of motion, rather than identifying or diagnosing medical conditions.
No
The provided text only describes the intended use and indications for use of a therapeutic ultrasound, TENS, Interferential, premodulated (IFC), NMS, Microcurrent, EMS, Hi-Volt, and Russian device. It does not contain a device description, which is necessary to determine if the device is software-only. The listed modalities are typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes therapeutic applications involving the direct treatment of the human body using modalities like therapeutic ultrasound, TENS, Interferential, etc. These are all external or non-invasive treatments applied to the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the body) to diagnose or provide information about a disease or condition.
The device described is a therapeutic device used for physical therapy and pain management, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Indications for Use:
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain relief, muscle spasms and joint contractures. 1.
- Relief of pain, muscle spasms and joint contractures that may be associated with: 2.
- · Adhesive capsulitis
- · Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
-
- Relief of sub-chronic, chronic pain and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring
For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:
- Symptomatic relief of chronic intractable pain 1.
-
- Post-traumatic acute pain
- Post-surgical acute pain 3.
Additionally for EMS, NMS, Hi-Volt and Russian:
- Relaxation of Muscle spasms 1.
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Maintaining or increasing range of motion
-
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Product codes (comma separated list FDA assigned to the subject device)
IMG, GZJ, LIH
Device Description
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Mentions image processing
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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
Not Found
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)
Not Found
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.
Not Found
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
§ 890.5860 Ultrasound and muscle stimulator.
(a)
Ultrasound and muscle stimulator for use in applying therapeutic deep heat for selected medical conditions —(1)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.(2)
Classification. Class II (performance standards).(b)
Ultrasound and muscle stimulator for all other uses —(1)Identification. An ultrasound and muscle stimulator 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 applies to the body electrical currents and that is intended for the treatment of medical conditions by means other than the generation of deep heat within body tissues and the stimulation or relaxation of muscles 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 ultrasound and muscle stimulator 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 ultrasound and muscle stimulator described in paragraph (b) of this section that was in commercial distribution before May 28, 1976. Any other ultrasound and muscle stimulator described in paragraph (b) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Shenzhen Dongdixin Technology Company, Limited % Kang Jian Ping No. 3 Building, Xilibaimang Xusheng Industrial Estate Nanshan District Shenzhen, China 518108
Re: K120217
Trade/Device Name: CT 1000 SonicStimu Combo Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and muscle stimulator Regulatory Class: Class II Product Code: IMG, GZJ, LIH Dated: undated Received: November 19, 2012
Dear Kang Jian Ping:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Letter Dated: November 21, 2012
1
Page 2 - Mr. Kang Jian Ping
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
File No: DDX -CT1000-FDA-04 Version: 1.2
DONGDIXIN
TECHNOLOGY CO., LTD.
莱迪欣
Indications for Use Statement
510(k) Number (K120217):
Device Name: SonicStimu Combo therapeutic device
Indications for Use:
Therapeutic Ultrasound
Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as:
- Pain relief, muscle spasms and joint contractures. 1.
- Relief of pain, muscle spasms and joint contractures that may be associated with: 2.
- · Adhesive capsulitis
- · Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
-
- Relief of sub-chronic, chronic pain and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring
For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:
- Symptomatic relief of chronic intractable pain 1.
-
- Post-traumatic acute pain
- Post-surgical acute pain 3.
Additionally for EMS, NMS, Hi-Volt and Russian:
- Relaxation of Muscle spasms 1.
-
- Prevention or retardation of disuse atrophy
-
- Increasing local blood circulation
-
- Muscle re-education
-
- Maintaining or increasing range of motion
-
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evalu (Division Sign-Off) (Division Sign-Off)
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