(134 days)
The intended use of the ELEXUS(PC-1450) is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The document is a US FDA 510(k) substantially equivalent letter for a powered wheelchair (Trade/Device name: Tacahe, later identified as ELEXUS(PC-1450)). It primarily addresses the regulatory approval process, confirming the device's substantial equivalence to a legally marketed predicate device and outlining general regulatory requirements. The "Indications for Use" section simply describes the intended purpose of the wheelchair.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
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NOV - 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
Mr. Will Ridgway Sales Manager Dalton Medical Corporation 1103 Venture Ct. Carrollton, Texas 75006
Re: K052534
Trade/Device name: Tacahe Regulation Number: 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 11, 2006 Received: January 12, 2006
Dear Mr. Ridgway:
This letter corrects our substantially equivalent letter of January 27, 2006.
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 (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.
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.
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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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Milliron
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Protecting and Promoting Public Health
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Indications for Use
The Children of the
K052534 510(k) Number (if known):
Device Name: ELEXUS(PC-1450)
Indications For Use:
The intended use of the ELEXUS(PC-1450) is to provide mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use xx (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NE-1 DF-1)
Concurrence of CDRH, Off ce of Device Evaluation (ODE)
2
(Division Sign-Off) (Division Sign-Ord) Restorative, and Neurological Londes
510(k) Number K052534
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).