Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
1. Pain relief, muscle spasms and joint contractures.
1. 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
1. 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
1. Post-traumatic acute pain
1. Post-surgical acute pain

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

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

For EMG

To determine the activation timing of muscles for:
1. Retaining of muscle activation
1. Coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

1. Relaxation muscle training
1. Muscle re-education

For EMG triggered Stim

1. Stroke rehab by muscle re-education
1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increase local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion

For DC Continuous Mode

Relaxation of muscle spasm 1)

Device Description

ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound, biofeedback and combination therapy. This product is designed to offer a multiple choices for clinician in one compact and integrated package.

A large control knobs located on the panel, allows clinician very easy to select different therapy mode and set therapeutic parameters. The award winning design offers a 5 inch Touch TFT LCD color display screen that can helps clinician to monitor the treatment information promptly.

In the electrotherapy mode, it's freedom for clinician to select one, two, three or four channels into therapy. A comprehensive set of current waveforms is available, targeting both pain management and muscle stimulation applications; interferential (4-pole), premodulated (2-pole interferential), Russian, NMS (Pulsed mode, burst mode), high volt, TENS, Microcurrent and Direct current.

The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz.

The EMG mode can provide us detail information about the organ-specific properties of a muscle through surface EMG electrodes. EMG biofeedback activity can couple with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle re-education.

The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic. NMS, NMS burst mode, and High Voltage pulsed Current.

AI/ML Overview

I am sorry, but without specific test data or performance metrics for the ComboRehab device, I cannot fill in the table for acceptance criteria and reported device performance. The provided text outlines the device's indications for use and lists the non-clinical tests performed, along with the standards it conforms to, but it does not contain quantifiable performance data or specific acceptance criteria for those performances.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies that would typically include acceptance criteria and their fulfillment.

However, I can provide the other requested information based on the text:

1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document states that "Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards." However, the specific reported device performance against numerical acceptance criteria is not detailed. The non-clinical tests focused on safety and electromagnetic compatibility per international standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. The document explicitly states "ComboRehab did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there was no "test set" in the context of clinical data for performance evaluation as typically understood for AI/medical device assessment. The non-clinical tests performed were likely on device prototypes or production units, not on human subjects or clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical tests were performed, there was no ground truth to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As no clinical tests were performed, there was no need for an adjudication method.

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
Not applicable. No multi-reader, multi-case clinical studies were conducted, as explicitly stated in the document. The device is a physical therapy device, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical therapy unit that provides various modalities (ultrasound, muscle stimulation, biofeedback). It is not an algorithm-only device or an AI system that would have "standalone" performance in the sense of a diagnostic or interpretive algorithm. Its performance is inherent to its physical operation and energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For the non-clinical tests performed, "ground truth" would refer to the adherence of the device's output to engineering specifications and international safety standards (e.g., electrical safety, electromagnetic compatibility, output intensity measurements). This is established through laboratory measurements and calibration against known standards, not clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set
Not applicable. No training set was used, as the device is not an AI/machine learning system that requires data training.

9. How the ground truth for the training set was established
Not applicable. No training set was used.

Summary

{0}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2015

Shenzhen Dongdixin Technology Co. Ltd. Jianping Kang M.R. No.3 Building, XiLiBaimang Industrial Estate Nanshan District Shenzhen, Guangdong, 518108 China

Re: [510(k) Number] K150436 Trade/Device Name: ComboRehab Regulation Number: 21 CFR 890.5860 Regulation Name: Ultrasound and Muscle Stimulator Regulatory Class: Class II Product Code: IMG, IPF, GZJ, GZI, LIH, HCC Dated: February 10, 2015 Received: October 13, 2015

Dear Mr. Jianping Kang:

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

{1}------------------------------------------------

forth in the quality systems (QS) 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S 同心

Carlos Peña, PhD, MS Division Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K150436

Device Name ComboRehab

Indications for Use (Describe)

Therapeutic Ultrasound

Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
1. Pain relief, muscle spasms and joint contractures.
1. 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
1. 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
1. Post-traumatic acute pain
1. Post-surgical acute pain

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

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

For EMG

To determine the activation timing of muscles for:
1. Retaining of muscle activation
1. Coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

1. Relaxation muscle training
1. Muscle re-education

For EMG triggered Stim

1. Stroke rehab by muscle re-education
1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increase local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion

{3}------------------------------------------------

Type of Use (Select one or both, as applicable)

X 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."

{4}------------------------------------------------

002_510 (k) Summary
Version: 1.2

Image /page/4/Picture/1 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, with the exception of a yellow line that crosses through the "X" in "DONGDIXIN". To the right of the English text is the company name in Chinese characters.

510(k) SUMMARY

ComboRehab, K (150436)

Date of Prepared:	02/10/2015
Submitter's Name:	Shenzhen Dongdixin Technology Co., Ltd
Address:	No. 3 Building, xilibaimang Xusheng Industrial EstateNanshan district Shenzhen, CHINA 518108
Contact person:	Jianping Kang
TEL:	+86(755) 27652471
FAX:	+86(755) 27652674
E-mail:	Kangjp@dundex.com

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a company logo for Dongdixin Technology Co., LTD. The logo has the company name in large, bold, dark blue letters. The "X" in "Dongdixin" is stylized with an orange line crossing through it. The full company name is written in smaller, dark blue letters below the main name, and there are three Chinese characters to the right of the company name.

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

1. Proposed Device:

1.1. Device Trade Name: ComboRehab

1.2. Requlation numbers and common names:

a. 21 CFR 890.5850-Stimulator,Muscle .Powered
b. 21 CFR 890.5860-Ultrasound and muscle stimulator
c. 21 CFR 882.5890-Transcutaneous electrical nerve stimulator for pain relief
d. 21 CFR 882.5050-Biofeedback device
e. 21 CFR 882.5810-External functional neuromuscular stimulator
1.3. Classification: Class II
1.4. Product Code: IMG, GZJ, GZI, IPF, LIH, HCC
1. Predicate Device:
- 2.1. Chattanooqa Vectra Genisys -- K062354
- 2.2. CT1000 SonicStimu Combo -- K120217

3. Description of Proposed Device:

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a diagonal line through the "X" in "DIXIN", which is in yellow. To the right of the English text is the company name in Chinese.

The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz.

4. Proposed Device Intended Use Statement:

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)
1. 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
1. 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)
1. Post-traumatic acute pain
1. Post-surgical acute pain

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

Relaxation of Muscle spasms 1)

{7}------------------------------------------------

002 510 (k) Summary Version: 1.2

DONGDI)

TECHNOLOGY CO.,

1. Prevention or retardation of disuse atrophy
1. Increasing local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion
1. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

For EMG

To determine the activation timing of muscles for:

Retaining of muscle activation 1)
1. Coordination of muscle activation

An indication of the force produced by muscle for control and maintenance of muscle contractions

Relaxation muscle training 1)
1. Muscle re-education

For EMG triggered Stim

1. Stroke rehab by muscle re-education
1. Relaxation of muscle spasms
1. Prevention or retardation of disuse atrophy
1. Increase local blood circulation
1. Muscle re-education
1. Maintaining or increasing range of motion

For DC Continuous Mode

Relaxation of muscle spasm 1)

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for DONGDIXIN TECHNOLOGY CO., LTD. The logo is in blue, except for a yellow line that crosses the "X" in DONGDIXIN. To the right of the English text is the company name in Chinese.

5. Technical and Performance Comparison

The following table compares the device to the predicate device with basic technological characteristics.

1	510K#	K	K120217	K062354
2	Device Name	ComboRehab	CT1000 SonicStimu Device	Vectra Genisys
3	Manufacturer	Shenzhen Dongdixin TechnologyCo., Ltd.	Shenzhen Dongdixin TechnologyCo., Ltd.	Chattanooga Group
4	Power Source	AC line	AC Line	AC line
	-Method of Line current isolation	Transformer	Transformer	Not stated in the Manual
	- Patient Leakage Current (μΑ)
	-Normal condition	d.c:0. a.c.:76.5	d.c:0. a.c.:78.9	Not stated in the Manual
	-Single fault condition	d.c:0. a.c.: 132.1	d.c:0. a.c.:135.8	Not stated in the Manual
5	Number of Output Modes	10	10	10
6	Number of Output Channels	4	2	2
	Synchronous Or Alternating	N/A	N/A	1&2 or 3&4
7	Constant Current	Optional	Optional	Optional
	Constant Voltage	Optional	Optional	Optional
8	Software/Firmware/Microprocessor	Yes	Yes	Yes
	Control
9	Automatic Overload Trip	Yes	Yes	Not Stated in the Manual
	Automatic Over Current Trip	Yes	Yes	Warning only, Overcurrent
10	Automatic No Load contact Trip	Yes	Yes	Warning only, Bad electrode contact
11	Automatic Shut off	Yes	Yes	Yes
12	Patient Override	Yes	No	Yes
	Control Method	Patient interrupt switch	ON/OFF, Hold or Stop	Patient interrupt switch
13	Indicator Display
	-On/Off Status	Yes	Yes	Yes
	-Voltage/Current Level?	Yes	Yes	Yes
	-Low Battery indicator	Yes	N/A	N/A
14	Timer Display	0-60 minutes	0-60 minutes	0-60 minutes
15	Standards	ISO14971, IEC 60601-1, IEC60601-1-2, IEC 60601-2-10,IEC60601-2-5, MDD 93/42/EEC,Annex II,	ISO14971, IEC 60601-1, IEC60601-1-2, IEC 60601-2-10,IEC60601-2-5, MDD 93/42/EEC,Annex II,	UL/IEC/EN 60601-1,IEC/EN60601-1-2, IEC 60601-2-5, IEC60601-2-10
16	Compliance with 21 CFR 898	Yes	Yes	Yes
17	Weight (Ibs.)	10.36	3.0	7
18	Dimensions (in.) HW L	10*7x15.5	9.87.23.2	8.811.37512.75
19	Housing Materials & Construction	Plastic	Plastic	Plastic

{9}------------------------------------------------

DONGDIXIN翡

TECHNOLOGY CO., LTD.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for DONGDIXIN Technology Co., LTD. The logo is in blue, with the exception of a yellow line that crosses through the "X" in "DIXIN". To the right of the English text is the company name in Chinese characters.

6. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

ComboRehab did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:

A IEC 60601-1 " Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance".
A 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 60601-2-10 " Medical Electrical Equipment -- Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators. (Neurology)s"
IEC 60601-2-5 "Medical electrical equipment - Part 2-5: Particular Requirements For The Basic Safety And Essential Performance Of Ultrasonic Physiotherapy Equipment"
IEC60601-2-40 "Medical electrical equipment - Part 2-40:Particular requirements for the safety of electromyographs and evoked response equipment"

7. Discussion of Clinical Tests Performed:

Not applicable

8. Conclusions:

The proposed device has the same intended use and similar characteristics as the predicate device, the CT1000 SonicStimu Device and Vectra Genisys. Moreover, bench testing, and safety repor documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device.

Thus, ComboRehab Device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.