SONICSTIMU COMBO THERAPEUTIC DEVICE

K120217 · Shenzhen Dongdixin Technology Co., Ltd. · IMG · Nov 21, 2012 · Physical Medicine

Device Facts

• Record ID: K120217
• Device Name: SONICSTIMU COMBO THERAPEUTIC DEVICE
• Applicant: Shenzhen Dongdixin Technology Co., Ltd.
• Product Code: IMG · Physical Medicine
• Decision Date: Nov 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 - 3. 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. - 2. Post-traumatic acute pain - Post-surgical acute pain 3. Additionally for EMS, NMS, Hi-Volt and Russian: - Relaxation of Muscle spasms 1. - 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

Device Story

The CT 1000 SonicStimu Combo is a multi-modality therapeutic device combining ultrasound and electrical muscle stimulation (TENS, IFC, NMS, Microcurrent, EMS, Hi-Volt, Russian). It delivers deep heat via ultrasound for musculoskeletal conditions and electrical stimulation for pain management and muscle rehabilitation. The device is intended for clinical use by healthcare professionals or for prescription-based patient use. It operates by applying ultrasound transducers or electrical stimulation electrodes to the patient's skin. The provider selects the modality and parameters based on the patient's condition to achieve pain relief, muscle relaxation, or improved circulation. The device provides therapeutic benefits by addressing chronic pain, joint stiffness, and muscle atrophy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combination device providing therapeutic ultrasound and electrical stimulation (TENS, EMS, IFC, NMS, Microcurrent, Hi-Volt, Russian). Class II device (Product codes: IMG, GZJ, LIH). Operates via electrical energy conversion to mechanical (ultrasound) and electrical (stimulation) outputs. Form factor is a tabletop or portable console with external applicators/electrodes.

Indications for Use

Indicated for patients requiring therapeutic deep heat for sub-chronic/chronic pain, muscle spasms, joint contractures, adhesive capsulitis, bursitis, myositis, soft tissue injuries, and scar tissue. Also indicated for symptomatic relief of chronic intractable, post-traumatic, or post-surgical pain, and for muscle relaxation, atrophy prevention, blood circulation, muscle re-education, range of motion maintenance, and 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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### 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

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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 [phone] or [phone] 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

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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
- 3. 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.
- 2. Post-traumatic acute pain
- Post-surgical acute pain 3.

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

- Relaxation of Muscle spasms 1.
- 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

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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