(267 days)
Not Found
No
The device description and intended use focus on standard therapeutic modalities (ultrasound, electrotherapy, EMG) with no mention of AI or ML algorithms for analysis, treatment planning, or any other function. The performance studies listed are focused on electrical and safety standards, not AI/ML performance metrics.
Yes
The device details multiple therapeutic applications, including pain relief, muscle spasm reduction, increasing range of motion, muscle re-education, and preventing disuse atrophy, which are all aimed at treating specific medical conditions.
No
The device is primarily a therapeutic device, providing various forms of electrotherapy and ultrasound for treatment purposes (e.g., pain relief, muscle relaxation, muscle re-education). While it has an "EMG mode" that provides information about muscle activation and force, this information is used for "retaining of muscle activation," "coordination of muscle activation," and "relaxation/muscle re-education," which are therapeutic goals. The EMG is a biofeedback tool to aid in rehabilitation, not for diagnosing a condition.
No
The device description clearly states it is a "four channels combination unit" that provides muscle stimulation, ultrasound, and biofeedback, and mentions physical components like "control knobs," a "Touch TFT LCD color display screen," and "applicators." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "four channels combination unit" providing "muscle stimulation, ultrasound, biofeedback and combination therapy." Its intended uses are focused on therapeutic applications like pain relief, muscle rehabilitation, and increasing range of motion.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its actions are external applications of energy (ultrasound, electrical stimulation) or measurement of physiological signals (EMG) for therapeutic or diagnostic purposes in vivo.
- Relevant Standards: The listed standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-2-5, IEC60601-2-40) are for medical electrical equipment, nerve and muscle stimulators, ultrasonic physiotherapy equipment, and electromyographs, all of which are consistent with a therapeutic and diagnostic device used on the body, not for analyzing samples from the body.
Therefore, this device falls under the category of therapeutic and diagnostic medical devices used directly on the patient, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Therapeutic Ultrasound
- Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
-
- 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
- · 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
-
- Post-traumatic acute pain
-
- Post-surgical acute pain
Additionally for NMS. NMS Burst, Hi-Volt and Russian:
-
- Relaxation of Muscle spasms
-
- 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
For EMG
- To determine the activation timing of muscles for:
-
- Retaining of muscle activation
-
- Coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
-
- Relaxation muscle training
-
- Muscle re-education
For EMG triggered Stim
-
- Stroke rehab by muscle re-education
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increase local blood circulation
-
- Muscle re-education
-
- Maintaining or increasing range of motion
For DC Continuous Mode
- Maintaining or increasing range of motion
-
Relaxation of muscle spasm
Product codes (comma separated list FDA assigned to the subject device)
IMG, IPF, GZJ, GZI, LIH, HCC
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.
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
Prescription Use
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)
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"
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
§ 890.5860 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
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:
-
- 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
- · 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
-
- Post-traumatic acute pain
-
- Post-surgical acute pain
Additionally for NMS. NMS Burst, Hi-Volt and Russian:
-
- Relaxation of Muscle spasms
-
- 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
For EMG
- To determine the activation timing of muscles for:
-
- Retaining of muscle activation
-
- Coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
-
- Relaxation muscle training
-
- Muscle re-education
For EMG triggered Stim
-
- Stroke rehab by muscle re-education
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increase local blood circulation
-
- Muscle re-education
-
- 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 Estate |
| Nanshan 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
-
- Predicate Device:
3. Description of Proposed Device:
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.
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.
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.
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)
-
- 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
-
- 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
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.,
-
- 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
For EMG
To determine the activation timing of muscles for:
- Retaining of muscle activation 1)
-
- Coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
- Relaxation muscle training 1)
-
- Muscle re-education
For EMG triggered Stim
-
- Stroke rehab by muscle re-education
-
- Relaxation of muscle spasms
-
- Prevention or retardation of disuse atrophy
-
- Increase local blood circulation
-
- Muscle re-education
-
- 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 Technology | ||
| Co., Ltd. | Shenzhen Dongdixin Technology | |||
| Co., 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, IEC | ||
| 60601-1-2, IEC 60601-2-10, | ||||
| IEC60601-2-5, MDD 93/42/EEC, | ||||
| Annex II, | ISO14971, IEC 60601-1, IEC | |||
| 60601-1-2, IEC 60601-2-10, | ||||
| IEC60601-2-5, MDD 93/42/EEC, | ||||
| Annex II, | UL/IEC/EN 60601-1,IEC/EN | |||
| 60601-1-2, IEC 60601-2-5, IEC | ||||
| 60601-2-10 | ||||
| 16 | Compliance with 21 CFR 898 | Yes | Yes | Yes |
| 17 | Weight (Ibs.) | 10.36 | 3.0 | 7 |
| 18 | Dimensions (in.) H*W * 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.