(81 days)
The Mechanical Wheelchairs are intended to provide mobility to persons restricted to a sitting position.
Not Found
The provided document is a 510(k) clearance letter from the FDA for several models of mechanical wheelchairs. It establishes substantial equivalence to legally marketed predicate devices.
This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.
The 510(k) process for these types of Class I mechanical devices typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This often involves engineering bench testing to ensure structural integrity, maneuverability, and other physical properties meet established standards for wheelchairs, rather than clinical studies with human participants or AI/ML algorithm evaluations.
Therefore, I cannot answer your specific questions as they pertain to AI/ML device evaluations, as the provided document is not about such a device. An AI/ML device submission would typically include a detailed clinical study report or performance testing report which outlines the information you are requesting.
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JUL 12 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Modern Rehabilitation Solutions Co., Ltd % Regulatory Insight, Inc. Mr. Kevin Walls 5401 S. Cottonwood Court Greenwood Village, Colorado 80121
Re: K094047 Trade/Device Name: 18" standard wheelchair (MS005-4) 22" heavy duty wheelchair (MS006-2) 28" bariatric wheelchair (MS010-1) 14" pediatric wheelchair (MS011-1) 18" reclining wheelchair (MS008-1) Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: December 29, 2009 Received: December 31, 2009
Dear Mr. Walls:
This letter corrects our substantially equivalent letter of March 22, 2010.
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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Page 2 - Mr. Kevin Walls
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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Barbary Buehno
Mark N. Melk Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _
Device Name:
: -
a. 18" standard wheelchair (MS005-4)
b. 22" heavy duty whoslain in the sta
22" heavy duty wheelchair (MS005-4)
28" bariatric whoolehair (MS006-2) b.
28" bariatric wheelchair (MS006)
14" pediatric wheelchair (MS010-1) C. ರ.
- 14" pediatric wheelchair (MS011-1)
18" reclining wheelchair (MS011-1) - e. 18" (
Indications for Use: The Mechanical Wheelchairs are intended to provide mobility to
persons restricted to a sitting position.
Kaunty K. Oram FOR M. MELKERSON
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K094047
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).