(196 days)
Not Found
No
The description mentions a "microprocessor-controlled traction system" with "operational software" to control force, cycle, and time based on physician settings. This indicates a programmed system, not one that learns or adapts using AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test data sets which are typical for AI/ML devices.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for medical purpose for use in conjunction with traction accessories... to exert therapeutic pulling forces on the patient's body." The "Device Description" also refers to it as a "medical device" that exerts "therapeutic pulling forces."
No
Explanation: The device, Everyway Traction System, model EVER-TRAC ET-800, is described as a medical device intended to exert therapeutic pulling forces on the patient's body. There is no mention of it being used to collect or analyze data for diagnostic purposes.
No
The device description explicitly details numerous hardware components including a driving motor, speed reduction gear, pulley assembly, spring, force and speed control unit, and a device housing. While it mentions operational software built into the control unit, it is clearly a physical 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:
- Intended Use: The intended use clearly states the device is used to "exert therapeutic pulling forces on the patient's body." This describes a physical therapy or rehabilitation application, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details mechanical components (motor, gears, pulleys) and control systems used to apply force. It does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of reagents, assays, sample handling, or any other elements typically associated with in vitro diagnostics.
In summary, the Everyway Traction System is a therapeutic device that applies physical force to the body, which is fundamentally different from an in vitro diagnostic device that analyzes samples outside of the body to provide diagnostic information.
N/A
Intended Use / Indications for Use
The Everyway Traction System, model EVER-TRAC ET-800 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses , to exert therapeutic pulling forces on the patient's body.
Product codes (comma separated list FDA assigned to the subject device)
ITH
Device Description
Everyway Traction Unit, model EVER-TRAC ET-800 is a medical device constructed for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
For this intended operation function, ET-800 is the combination of driving moter, speed reduction gear, pulley assembly, spring, force and speed control unit... etc. All of the operational parts as above mentioned are mounted on the frame of device housing.
The pulling force for ET-800 is generated by the combination of induction motor and speed reduction gear. For the operation of ET-800, the single phase AC power shall be supplied from the general wall socket of house (Note: In USA, the power supply specification is single phase, 60Hz, 120V).
Basically ET-800 is a microprocessor-controlled traction system in which the operational software is built inside the control unit to properly control the exertion and release of pulling force according to the setting for applying force, operation cycle, and operation time prescribed by the physician.
To ensure the safety of operation, the device was designed and constructed to provide the following safety protection: Manual release, Auto shutdown, and Safe protect. In addition, the device also provides warning alarm function for same near dangerous situations as mentioned in user's manual.
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)
Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of EVER-TRAC ET-800 are as the followings: 1> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory. 2> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings: No particular Clinical Test was conducted for Everyway Traction Unit, model EVER-TRAC ET-800.
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
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).
0
K112074
PAGE 1 OF 2
EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.
3F1. No. 5. Lane 155. Sec. 3.Peishen Rd. Shen Keng Hsiang, Taipei Hsien, Taiwan,
FEB = 1 2012
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at June 15, 2011.
The assigned 510(k) number is:
-
- Submitter's Identifications:
Establishment: EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Registration Number: 9616877 Operations: Manufacturer
- Submitter's Identifications:
Owner/Operator:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address : 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Contact Person: Robert Tu Phone : 886-2-2662-0038 Fax No: 886-2-2664-5566 e-mail : tu922@ms35.hinet.net
-
- Name of the Device: Everyway Traction Unit, model EVER-TRAC ET-800.
-
- Information of the 510(k) Cleared Device (Predicate Device): Ever Prosperous Traction System model DIGIT-TRAC 930(K052453)
- Classification Information: Trade/Device Name: Everyway Traction Unit, model EVER-TRAC ET-800. Regulation Number: 21 CFR Part 890.5900 Regulation Name: Powered Traction Equipment Regulatory Class: II Product Code: ITH
-
- Device Description:
Everyway Traction Unit, model EVER-TRAC ET-800 is a medical device constructed for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.
- Device Description:
For this intended operation function, ET-800 is the combination of driving moter, speed reduction gear, pulley assembly, spring, force and speed control unit... etc. All of the operational parts as above mentioned are mounted on the frame of device housing.
1
EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.
3F1. No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,
The pulling force for ET-800 is generated by the combination of induction motor and speed reduction gear. For the operation of ET-800, the single phase AC power shall be supplied from the general wall socket of house (Note: In USA, the power supply specification is single phase, 60Hz, 120V).
Basically ET-800 is a microprocessor-controlled traction system in which the operational software is built inside the control unit to properly control the exertion and release of pulling force according to the setting for applying force, operation cycle, and operation time prescribed by the physician.
To ensure the safety of operation, the device was designed and constructed to provide the following safety protection: Manual release, Auto shutdown, and Safe protect. In addition, the device also provides warning alarm function for same near dangerous situations as mentioned in user's manual.
-
- Intended Use:
The Everyway Traction System, model EVER-TRAC ET-800 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses , to exert therapeutic pulling forces on the patient's body
- Intended Use:
-
- Comparison to the 510(k) Cleared Device (Predicate Device): The Everyway Traction Unit, model EVER-TRAC ET-800 is substantially equivalent to the Ever Prosperous Traction System model DIGIT-TRAC 930(K052453) without any significant difference in main technological and operational feature.
-
- Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of EVER-TRAC ET-800 are as the followings: 1> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory. 2> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
-
- Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings: No particular Clinical Test was conducted for Everyway Traction Unit, model EVER-TRAC ET-800.
-
- Conclusions
The Everyway Traction Unit, model EVER-TRAC ET-800, has the same intended use and technological characteristics as the cleared device of Ever Prosperous Traction System model DIGIT-TRAC 930(K052453. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted model could maintain the same safety and effectiveness as that of cleared device.
In the other words, Everyway Traction Unit, model EVER-TRAC ET-800 is substantial equivalent with the Ever Prosperous Traction System model DIGIT-TRAC 930(K052453) .
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2012
Everyway Medical Instruments Co., Ltd. % Mansour Consulting LLC Mr. Jay Mansour 845 Aronson Lake Court Roswell, Georgia 30075
Re: K112074
Trade/Device Name: Everyway Traction Unit, Model EVER-TRAC ET-800 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH Dated: December 30, 2011 Received: January 03, 2012
Dear Mr. Mansour:
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
3
Page 2 - Mr. Jay Mansour
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 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 A. Millerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EVERYWAY EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.
3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,
Indications For Use
510(k) Number (if known): _
Device Name: Everyway Traction Unit, model EVER-TRAC ET-800.
Indications For Use:
The Everyway Traction System, model EVER-TRAC ET-800 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses , to exert therapeutic pulling forces on the patient's body.
Prescription Use ブ (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
///
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112074
Page 1 of _ 1
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