(90 days)
Not Found
Not Found
No
The description details a mechanical wheelchair with no mention of software, AI, or ML components.
No
The device, a wheelchair, provides mobility but does not actively diagnose, treat, or prevent disease, nor does it restore, correct, or modify body functions or structure in a therapeutic manner. It is a supportive device.
No
The device, a wheelchair, is described as providing mobility to children and does not perform any diagnostic functions like detecting, monitoring, or predicting a medical condition.
No
The device description clearly states it consists of an aluminum frame, wheels, and casters, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide mobility to children limited to a sitting position." This is a physical support and mobility function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a wheelchair, which is a mechanical device for mobility.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Multi Frame wheelchair, as described, falls under the category of a medical device for mobility and support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Multi Frame's intended function and use is provide mobility to children limited to a sitting position.
Product codes
IOR
Device Description
The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning.
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
children
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image contains a circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized depiction of an eagle or bird in flight, rendered in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper perimeter of the circle, also in black. The overall design is simple and conveys a sense of official government branding.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
APR 1 2 2010
R82 A/S % Snug Seat, Inc. President Mr. Kirk MacKenzie P.O. Box 1739 Matthews, North Carolina 28106
Re: K100084
Trade/Device Name: Multi Frame Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: December 15, 2009 Received: January 12, 2010
Dear Mr. MacKenzie:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Kirk MacKenzie
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/CDRH0ffices/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/ReportalProblem/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 vours
cerely yours,
For
N. Mellow
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K100084 Device Name: Multi Frame Wheelchair Indications For Use: The Multi Frame's intended function and use is provide mobility to children limited to a sitting position. The Wheelchair consists primarily of an aluminum frame, large rear wheels with hand rims for propelling the wheelchair or smaller rear wheels for attendant-only use, and smaller front privoting casters for steering and turning. ····Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDF leyice Evaluation (ODE)
(Division Sign-Off (Division Sign=QIC). Orthopedio.
Division of Surgices Division of Bargerive Devices
510(k) Number K00084
Page 1 of