(352 days)
The device is a product which changes people's position from standing to sitting or sitting to standing and any position in between. The product provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it should not be driven in the standing position on uneven ground.
The device changes people's position in/from seating or/to standing but also any position in between. It provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it is not allowed to drive in standing position on uneven ground. The device is powered by a 24 V DC/36 Ah, lead-acid battery, approximate driving range on fully charged battery is up to 32 km(19 miles), depending on use and the terrain the wheelchair is driven on, and which maximum speed is up to 8 km/h (5 mph). The device is middle wheels with motors driven and controlled by the DYNAMIC DX2 controller.
The provided text describes a 510(k) summary for the EOR 1 Stand-Up Power Wheelchair, focusing on its substantial equivalence to a predicate device and compliance with various international standards. It does not contain information about the acceptance criteria or a study proving device performance in the context of clinical or AI-powered diagnostic devices.
Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, performance studies, sample sizes, expert ground truth, or MRMC studies, as this information is not present in the provided document. The document focuses on establishing equivalence for a physical medical device (a wheelchair).
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Applicant
Name: E-TENG TECHNOLOGY INC.
Address: No. 108, Masu Rd., Wanli Dist., New Taipei City, 207, Taiwan Contact person: Mr. Y. W. Chen, Design Manager Phone: +886-2-2492-3888 Fax: +886-2-2492-3888
Date prepared: Aug. 08, 2013
Device
Trade name: EOR 1 Stand-Up Power Wheelchair
Common (generic) name: Standup wheelchair
Classification name: Standup wheelchair
Medical specialty (Panel): Physical Medicine Device
Regulation number: 890.3900
Product Code: IPL
Classification: Class II
Predicate devices
Trade name: LEVO Combi Manufacture: LEVO AG 510(k) number: K030893 Regulation number: 890.3900 Product Code: IPL Classification: Class II
Intend use of device
The device is a product which change people's position from standing to sitting or sitting to standing and any position in between. The product provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it should not be driven in the standing position on uneven ground.
Device description:
The device changes people's position in/from seating or/to standing but also any position in between. It provides indoor and outdoor mobility on surfaces like tar,
AUG 0 9 2013
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grass and gravel. However, it is not allowed to drive in standing position on uneven ground.
The device is powered by a 24 V DC/36 Ah, lead-acid battery, approximate driving range on fully charged battery is up to 32 km(19 miles), depending on use and the terrain the wheelchair is driven on, and which maximum speed is up to 8 km/h (5 mph). The device is middle wheels with motors driven and controlled by the DYNAMIC DX2 controller.
Summary of non-clinical tests
The EOR 1 standup power wheelchair complied with the requirements of ISO 7176-1, ISO 7176-2, ISO 7176-3, ISO 7176-4, ISO 7176-5, ISO 7176-6, ISO 7176-9, ISO 7176-10, ISO 7176-11, ISO 7176-13, ISO 7176-14, ISO 7176-15, ISO 7176-16, ISO 7176-21, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 14971, ANSI/RESNA WC.Vol.1 Sec. 7, Sec. 8 and Sec. 20, CISPR 11, IEC 61000-4-2, IEC 61000-4-3.
Statement of substantial equivalence
The EOR 1 standup power wheelchair and the predicate device all are the products which change a people position not only from sitting to standing and standing to sitting but also reclines backrest and lifts leg positions. They provide indoor and outdoor mobility.
They have the same user interface while there are minor differences between the devices do not alter the intended use function and use of the device. Moreover, the non-clinical tests and the predicate comparisons demonstrate that these differences in their technological characteristics do not raise any questions as to the safety and effectiveness, therefore the EOR 1 standup powered wheelchair is substantially equivalent to the predicate device.
Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, E-TENG TECHNOLOGY INC. concludes that, EOR 1 standup power wheelchair is substantially equivalent to predicate device as described herein.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
August 9, 2013
E-TENG Technology, Inc % Ms. Junnata Chang 16-F2 (16A), No. 462, Sec. 2 ChongDe Rd., Betin Dist. Taichung, China (Taiwan) 406
Re: K122562
Trade Name: E-TENG Model EOR 1 Regulation Number: 21 CFR 890,3900 Regulation Name: Standup Wheelchair Regulatory Class: Class II Product Code: IPL Dated: June 20, 2013 Received: July 2, 2013
Dear Ms. Chang:
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
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Page 2 - Ms. Junnata Chang
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/ycm 115809.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 yours,
Joyce M. Whang -S
for 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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Indications for Use
510(k) Number (if known): _K122562
Device Name: EOR 1 Stand-Up Power Wheelchair
Indications For Use:
The device is a product which changes people's position from standing to sitting or sitting to standing and any position in between. The product provides indoor and outdoor mobility on surfaces like tar, grass and gravel. However, it should not be driven in the standing position on uneven ground.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use X (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)
Jovce M. Whang
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K122562
Page 1 of 1
§ 890.3900 Standup wheelchair.
(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).