(112 days)
Not Found
Not Found
No
The summary describes a manual wheelchair and contains no mention of AI, ML, or related concepts like image processing or performance studies typically associated with AI/ML devices.
No
The device, a manual wheelchair, is for mobility assistance, not for treating or diagnosing a medical condition.
No
Explanation: The device is described as a "Manual Wheelchair" intended for mobility assistance, which is not a diagnostic function. There is no mention of it being used for detecting, monitoring, or diagnosing any medical condition.
No
The device is described as "Manual Wheelchairs," which are physical hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for mobility assistance for people needing it, in various settings. This is a physical aid, not a diagnostic test performed on samples taken from the human body.
- Device Description: While "Not Found" is listed, the intended use clearly describes a physical device for mobility.
- No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- No mention of diagnosis: The purpose is to provide mobility, not to diagnose a disease or condition.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. A manual wheelchair does not fit this description.
N/A
Intended Use / Indications for Use
These Manual Wheelchairs are to be used by people needing mobility assistance.
The manual Wheelchairs will be used for personal use, and for commercial use in venues such as Theme parks, Airports, and Hospitals.
Product codes
IOR
Device Description
Not Found
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)
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 shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1998 OCT
Mr. Ron Mosetich Vice President Sriram Enterprises D.B.A. Momentum Group 4388 36th Street Orlando, Florida 32811
Re: K982099 Trade Name: Momentum No. FS008 Wheelchair Requlatory Class: I Product Code: IOR Dated: August 26, 1998 Received: August 28, 1998
Dear Mr. Mosetich:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Ron Mosetich
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Whitton, Ph.D., M
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) NUMBER (IF KNOWN) : K982099
Manual Wheelchair DEVICE NAME:
INDICATIONS FOR USE:
These Manual Wheelchairs are to be used by people needing mobility assistance.
The manual Wheelchairs will be used for personal use, and for commercial use in venues such as Theme parks, Airports, and Hospitals.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(Optional Format 1-2-96)
Posed
Division (Sign-Off)
Division of General Restorative Devices
510(k) Number: K982099