(130 days)
Not Found
No
The device description focuses on manual control via buttons and adjustable intensity, with no mention of adaptive algorithms, learning capabilities, or data processing that would indicate AI/ML. The performance studies section also does not mention any AI/ML-specific validation.
Yes
The device is described as a stimulator for pain relief and muscle stimulation, with indicated uses including symptomatic relief of pain, relaxation of muscle spasms, and prevention of disuse atrophy. These are therapeutic applications aimed at treating or alleviating medical conditions.
No
The device description and intended uses clearly state that the device is a stimulator for pain relief and muscle stimulation, designed to send electrical currents for therapeutic purposes, not for diagnosing conditions.
No
The device description clearly outlines a physical device with a molded plastic case, LCD display, keypad, and battery storage compartment, which are all hardware components. The software controls the parameters but is integrated into this physical hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the MT9000 Series Stimulator is a Transcutaneous Electrical Nerve Stimulator and muscle stimulator. It sends electrical current to the body via electrodes applied on the skin. Its intended uses are for pain relief, muscle stimulation, and related therapeutic purposes.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient.
Therefore, the MT9000 Series Stimulator falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Device Name: MT9000 Combo Stimulator, MT9001 TENS Stimulator, MT9002 EMS Stimulator, MT9003 IF Stimulator, MT9000 MICROCURRENT Stimulator
Indications for Use:
MT9000 Combo TENS/EMS/IF/MIC Stimulator
For TENS mode
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
For EMS mode
- Relaxation of muscle spasm
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
For IF mode
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
For MIC mode
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
MT9001 TENS Stimulator
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
MT9002 EMS Stimulator
- Relaxation of muscle spasm
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
MT9003 IF Stimulator
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
MT9004 MICROCURRENT Stimulator
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain
- Post surgical pain
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ, LIH
Device Description
The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003, MT9004, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The five models MT9000, MT9001, MT9002, MT9003 and MT9004 have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.
The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.
The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.
The MT9000 Combo TEN/EMS/IF/MIC Stimulator is the combination unit with the TENS, EMS. IF and MICROCURRENT functions, the function can be selected by press buttons. The range of settings is identical to those of MT9001, MT9002, MT9003 and MT9004. The difference on the five units can be identified by the LCD display.
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
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)
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 safetv".
- A IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard"
- A IEC 60601-2-10 "Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators"
The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003 and MT9004, has the same intended use and technological characteristics as the predicate device of Sonicator Plus 940, Model ME940 device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the MT9000 Series Electro-Stimulator is substantially equivalent to the predicate device.
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
File No: WMI-04-MT9000-FDA-05 Version: 1.2 Date: Feb. 16, 2010
510(k) SUMMARY
FEB 1 2 2010
)
: ; ﻪ ﺍﻟ
MT9000 Series Electro-Stimulator, K (
| Submitter's Name: | Shenzhen Dongdixin Technology Co., Ltd. |
|---|---|
| Address: | No.3bldg. xiliyangguang industrial estae xilixiaobaimang |
| Nanshan district Shenzhen, China 518108 | |
| Telephone: | +86(755) 27652471 |
| Fax: | +86(755) 27652674 |
| E-Mail: | info@dundex.com |
| microcong@gmail.com | |
| Contact: | Zhigang Zhao |
| Date Prepared: | Sep 10 2009 |
Section 05-Page 1 of 5
1
File No: WMI-04-MT9000-FDA-05 Version: 1.2 Date: Feb. 16, 2010
1. Proposed Device:
- A.
B.
C.
| Trade Name: | MT9000 Combo TENS/EMS/IF/MIC Stimulator
MT9002 EMS Stimulator |
|----------------------|------------------------------------------------------------------|
| Classification Name: | Stimulator, Muscle, Powered |
| Regulation Number: | 890.5850 |
| Product Code: | IPF |
| Device Class: | II |
| Trade Name: | MT9001 TENS Stimulator
MT9004 MICROCURRENT Stimulator |
| Classification Name: | Stimulator, Nerve, Transcutaneous. For pain relief |
| Regulation Number: | 882.5890 |
| Product Code: | GZJ |
| Device Class: | II |
| Trade Name: | MT9003 IF Stimulator |
| Classification Name: | Interferential current therapy |
| Regulation Number: | Unclassified |
| Product Code: | LIH |
Predicate Device: 2.
Legally Marketed Device: Sonicator Plus 940, ME940 Manufacturer: Mettler Electronics Corp 510(k) Number: K071137
Device Class:
Description of Proposed Device: 3.
The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003, MT9004, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The five models MT9000, MT9001, MT9002, MT9003 and MT9004 have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular.
. "
Section 05-Page 2 of 5
2
File No: WMI-04-MT9000-FDA-05 Version: 1.2 Date: Feb.16, 2010
The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.
The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.
The MT9000 Combo TEN/EMS/IF/MIC Stimulator is the combination unit with the TENS, EMS. IF and MICROCURRENT functions, the function can be selected by press buttons. The range of settings is identical to those of MT9001, MT9002, MT9003 and MT9004. The difference on the five units can be identified by the LCD display.
Proposed Device Intended Use Statement: 4.
Device Name:
MT9000 Combo Stimulator, MT9001 TENS Stimulator, MT9002 EMS Stimulator,
MT9003 IF Stimulator, MT9000 MICROCURRENT Stimulator
Indications for Use:
MT9000 Combo TENS/EMS/IF/MIC Stimulator
For TENS mode
-
- Symptomatic relief of chronic intractable pain,
-
- Post traumatic pain
-
- Post surgical pain
For EMS mode
-
- Relaxation of muscle spasm
- Increase of local blood flow circulation 2.
- Prevention or retardation of disuse atrophy 3.
- Muscle re-education 4.
- Maintaining or increasing range of motion. 5.
- Immediate post-surgical stimulation of muscles to prevent venous 6. thrombosis
Section 05-Page 3 of 5
3
File No: WMI-04-MT9000-FDA-05 Version: 1.2 Date: Feb.16, 2010
For IF mode
-
- Symptomatic relief of chronic intractable pain,
-
- Post traumatic pain
- Post surgical pain 3.
For MIC mode
- Symptomatic relief of chronic intractable pain, 】.
-
- Post traumatic pain
- Post surgical pain 3.
MT9001 TENS Stimulator
-
- Symptomatic relief of chronic intractable pain,
-
- Post traumatic pain
-
- Post surgical pain
MT9002 EMS Stimulator
- Relaxation of muscle spasm 1.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
- Muscle re-education 4.
- Maintaining or increasing range of motion. 5.
- Immediate post-surgical stimulation of muscles to prevent venous 6. thrombosis
MT9003 IF Stimulator
- Symptomatic relief of chronic intractable pain, 1.
-
- Post traumatic pain
- Post surgical pain 3.
MT9004 MICROCURRENT Stimulator
- Symptomatic relief of chronic intractable pain, l.
- Post traumatic pain 2.
- Post surgical pain 3.
5. Biocompatibility Certification:
Electrodes to be provided with this device are from the manufacturer Top-Rank Health Care Equipment Co., Ltd (K070612) who submitted in 2007.
The shell of device is used ABS material has passed Biocompatibility Section 05-Page 4 of 5
4
Caretalk®
File No: WMI-04-MT9000-FDA-05 Version: 1.2 Date: Feb. 16, 2010
testing in Jiangsu TUV Product Service Ltd. Shanghai Branch. Identification No: 080960.
6. Technological Characteristics and Substantial Equivalence
Both the MT9000 Series Electro-Stimulator and the Sonicator Plus 940, ME940 Stimulator have the same intended use, fundamental technology, and operation characteristics. A side-by-side comparison of the MT9000 Series Electro-Stimulator and the cited predicate devices is included in the 510(k). The MT9000 Series Electro-Stimulator is substantially equivalent to the technologies provided by the predicate devices.
Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:
The MT9000 Series Electro-Stimulator 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 safetv".
- A IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for safety - Collateral Standard"
- A IEC 60601-2-10 "Medical electrical equipment - Part 2: Particular requirements for the safety of nerve and muscle stimulators"
Conclusions: 8.
- . The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003 and MT9004, has the same intended use and technological characteristics as the predicate device of Sonicator Plus 940, Model ME940 device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in the submitted models could maintain the same safety and effectiveness as that of predicate device. In the other words, those engineering difference do not affect the intended use or alter the fundamental scientific technology of the device. Thus, the MT9000 Series Electro-Stimulator is substantially equivalent to the predicate device.
5
Image /page/5/Picture/0 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" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Shenzhen Dongdixin Technology Co., Ltd % Mr. Zhigang Zhao No. 3 Bldg. Xiliyangguang Industrial Estate Xilixiaobaimang Nanshan District Shenzhen, CN-44, Guangdong Province People's Republic of China 518108
FEB 1 2 2010
Re: K093138
Trade/Device Name: MT9000 Combo TENS/EMS/IF/MIC Stimulator, MT 9001 TENS Stimulator, MT9002 EMS Stimulator, MT9003 IF Stimulator, MT9004 Microcurrent Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, GZJ, LIH
Dated: February 2, 2010 Received: February 2, 2010
Dear Mr. Zhao:
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
6
Page 2 - Mr. Zhigang Zhao
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 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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kachilliam M. Rogers ACTING DSORD DIRECTOR
FOR Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Carotalk®
File No: WMI-04-MT9000-FDA-04 Version: 1.2 Date: Feb.16, 2010
Indications for Use
510(k) Number (
Device Name:
MT9000 Combo TENS/EMS/IF/MIC Stimulator, MT9001 TENS Stimulator, MT9002 EMS Stimulator, MT9003 IF Stimulator, MT9004 MICROCURRENT Stimulator
Indications for Use:
MT9000 Combo TENS/EMS/IF/MIC Stimulator
For TENS mode
-
l . Symptomatic relief of chronic intractable pain,
): -
- Post traumatic pain
-
Post surgical pain 3.
For EMS mode
-
- Relaxation of muscle spasm
-
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy 3.
- Muscle re-education 4.
- న. Maintaining or increasing range of motion.
-
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
For IF mode
-
- Symptomatic relief of chronic intractable pain,
- Post traumatic pain 2.
- Post surgical pain 3.
For MIC mode
- Symptomatic relief of chronic intractable pain, 1.
- Post traumatic pain 2.
- Post surgical pain 3.
MT9001 TENS Stimulator
- Symptomatic relief of chronic intractable pain, 1.
- Post traumatic pain 2.
-
- Post surgical pain
FOR M. MELKERSEN
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Section 04 -Page 1 of 2
510(k) Number
8
Image /page/8/Picture/0 description: The image shows the word "Caretalk" in a stylized font. The letters are outlined in black, giving them a distinct appearance. A circled "R" trademark symbol is located to the right of the word.
File No: WMI-04-MT9000-FDA-04 Version: 1.2 Date: Feb.16, 2010
MT9002 EMS Stimulator
- Relaxation of muscle spasm l.
-
- Increase of local blood flow circulation
-
- Prevention or retardation of disuse atrophy
-
- Muscle re-education
-
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles to prevent venous 6. thrombosis
MT9003 IF Stimulator
-
- Symptomatic relief of chronic intractable pain,
-
- Post traumatic pain
-
- Post surgical pain
MT9004 MICROCURRENT Stimulator
-
- Symptomatic relief of chronic intractable pain.
-
- Post traumatic pain
-
- Post surgical pain
Prescription Use (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 Evaluation (ODE)
FOR MJ MELKERSON
sion Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093138
Section 04 -Page 2 of 2